search
Back to results

Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

Primary Purpose

Hemorrhagic Stroke

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Granules of Shengdi Dahuang Decoction
Placebo
Sponsored by
ShuGuang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Stroke focused on measuring acute hemorrhagic stroke, Shengdi Dahuang Decoction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Meet the diagnostic criteria of acute intracerebral hemorrhage;
  2. CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is <80ml;
  3. The time from onset to confirmed diagnosis by CT scan is within 4 hours;
  4. Enrolled and receive treatment within 12 hours from onset;
  5. Age ≥18 years old;
  6. Obtain approval from the patient or family members.

Exclusion Criteria:

  1. The time from onset to confirmed diagnosis by CT scan is over 4 hours;
  2. CT scan indicate that the sites of hemorrhage are in the cerebellum, brainstem and ventricle (note: in case of cerebral parenchymal hemorrhage combined with ventricular hemorrhage, patients will be excluded if the volume of ventricular hemorrhage is the larger one);
  3. The volume of hematoma is above 80ml;
  4. Glasgow Coma Scale (GCS) is ≤ 5 points;
  5. The time from onset to confirmed diagnosis is over 12 hours;
  6. Have a surgical treatment planning within 24 hours;
  7. Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons;
  8. Patients with disabilities before onset (modified mRS score > 2);
  9. Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system;
  10. Patients who have participated in other clinical trials within the past 1 month;
  11. Pregnant or nursing women;
  12. Allergic constitution (allergic to more than two kinds of food or medications).

Sites / Locations

  • Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCMRecruiting
  • Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong UniversityRecruiting
  • Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji UniversityRecruiting
  • Shuguang Hospital affiliated with Shanghai University of TCMRecruiting
  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Shengdi Dahuang Decoction

Placebo

Arm Description

To clarify the clinical effects of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke and to explore the possible mechanism. Participants will take the granules of Shengdi Dahuang Decoction that contains 15 grams of rehmannia and 5 grams of rhubarb, one pack per time, twice a day for 7 days.

To explore the effective clinical therapy in acute hemorrhagic stroke. Participants will take placebo contains 2% rehmannia and rhubarb, one pack per time, twice a day for 7 days.

Outcomes

Primary Outcome Measures

Disability rate
Modified Rankin Scale score (mRS) will be graded on the 90th day after onset (mRS score ranges from 0 point (no symptoms at all) to 5 points (severe disability)).
Mortality rate on the 7th day
The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.

Secondary Outcome Measures

Mortality rate on the 90th day
The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.
Severity of neurological deficit
National Institute of Health Stroke Scale (NIHSS) will be used to assess the severity of neurological deficit on the 7th day after treatment. NIHSS score ranges from 0 point to 42 points. More severe neurological deficit could be observed in participants with the higher score.
The proportion of hematoma enlargement cases
All participants will reexamine the skull CT scan 24 hours after onset. The volume of hematoma (ml) increases more than 6ml or 33% relative increment than original volume is defined as the expansion of hematoma. The proportion of hematoma enlargement cases (%) will be compared between different groups.
Severity of edema
All participants will reexamine the skull CT scan on the 7th day after treatment. The volume (ml) of edema and hematoma will be calculated respectively. The ratio of edema volume and hematoma volume represents the severity of edema.

Full Information

First Posted
December 6, 2019
Last Updated
December 13, 2019
Sponsor
ShuGuang Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04200781
Brief Title
Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke
Official Title
A Randomized, Controlled, Double-blind, Multi-center Clinical Study of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ShuGuang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke by the randomized, controlled, double-blind, multi-center trial design project.
Detailed Description
The main purpose of the study is to observe the clinical efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke. This project is funded by Science and Technology Commission of Shanghai Municipality and will be carried out in 5 hospitals. Investigators will recruit 464 participants who meet the inclusion criteria and agree to participate in the research. Participants will be randomly assigned into experimental or placebo group. Granules of Shengdi Decoction is the therapeutic drug used in the experimental group. Each pack of the test drug contains 15 grams of rehmannia and 5 grams of rhubarb. While for the placebo group, each pack contains 2% rehmannia and rhubarb. Participants will receive a follow-up observation in the following 90 days. Modified Rankin Scale score (mRS), the mortality rate on day 7 and day 90 after treatment, National Institute of Health Stroke Scale (NIHSS), expansion rate of hematoma, the degree of edema and the expressions of inflammatory indicators will be detected to evaluate the clinical efficacy of Shengdi Dahuang Decoction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Stroke
Keywords
acute hemorrhagic stroke, Shengdi Dahuang Decoction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
464 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shengdi Dahuang Decoction
Arm Type
Experimental
Arm Description
To clarify the clinical effects of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke and to explore the possible mechanism. Participants will take the granules of Shengdi Dahuang Decoction that contains 15 grams of rehmannia and 5 grams of rhubarb, one pack per time, twice a day for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
To explore the effective clinical therapy in acute hemorrhagic stroke. Participants will take placebo contains 2% rehmannia and rhubarb, one pack per time, twice a day for 7 days.
Intervention Type
Drug
Intervention Name(s)
Granules of Shengdi Dahuang Decoction
Other Intervention Name(s)
Chinese Herbal Compound
Intervention Description
Shengdi Dahuang Decoction contains Shengdi (rehmannia) and Dahuang ( rhubarb). Each pack of the granules of Shengdi Dahuang Decoction contains 15 grams of rehmannia and 5 grams of rhubarb.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo of Chinese Herbal Compound
Intervention Description
Placebo granules has the same appearence, weight, shape and color as the experimental drug.
Primary Outcome Measure Information:
Title
Disability rate
Description
Modified Rankin Scale score (mRS) will be graded on the 90th day after onset (mRS score ranges from 0 point (no symptoms at all) to 5 points (severe disability)).
Time Frame
90 days
Title
Mortality rate on the 7th day
Description
The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Mortality rate on the 90th day
Description
The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.
Time Frame
90 days
Title
Severity of neurological deficit
Description
National Institute of Health Stroke Scale (NIHSS) will be used to assess the severity of neurological deficit on the 7th day after treatment. NIHSS score ranges from 0 point to 42 points. More severe neurological deficit could be observed in participants with the higher score.
Time Frame
7 days
Title
The proportion of hematoma enlargement cases
Description
All participants will reexamine the skull CT scan 24 hours after onset. The volume of hematoma (ml) increases more than 6ml or 33% relative increment than original volume is defined as the expansion of hematoma. The proportion of hematoma enlargement cases (%) will be compared between different groups.
Time Frame
24 hours
Title
Severity of edema
Description
All participants will reexamine the skull CT scan on the 7th day after treatment. The volume (ml) of edema and hematoma will be calculated respectively. The ratio of edema volume and hematoma volume represents the severity of edema.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the diagnostic criteria of acute intracerebral hemorrhage; CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is <80ml; The time from onset to confirmed diagnosis by CT scan is within 4 hours; Enrolled and receive treatment within 12 hours from onset; Age ≥18 years old; Obtain approval from the patient or family members. Exclusion Criteria: The time from onset to confirmed diagnosis by CT scan is over 4 hours; CT scan indicate that the sites of hemorrhage are in the cerebellum, brainstem and ventricle (note: in case of cerebral parenchymal hemorrhage combined with ventricular hemorrhage, patients will be excluded if the volume of ventricular hemorrhage is the larger one); The volume of hematoma is above 80ml; Glasgow Coma Scale (GCS) is ≤ 5 points; The time from onset to confirmed diagnosis is over 12 hours; Have a surgical treatment planning within 24 hours; Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons; Patients with disabilities before onset (modified mRS score > 2); Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system; Patients who have participated in other clinical trials within the past 1 month; Pregnant or nursing women; Allergic constitution (allergic to more than two kinds of food or medications).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyu Yu
Phone
86-021-20256378
Email
doctorxiaoyu@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofei Yu
Organizational Affiliation
Shuguang Hospital affiliated with Shanghai University of TCM
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Wang
Phone
+86-13816566556
Email
13816566556@163.com
Facility Name
Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyan Xiang
Phone
86-18930173850
Email
xiang_jing_yan@aliyun.com
Facility Name
Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyu Zhou
Phone
86-18049929570
Email
13564532819@163.com
Facility Name
Shuguang Hospital affiliated with Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Yu
Phone
86-13331978806
Email
doctorxiaoyu@sina.com
Facility Name
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Han
Phone
86-13917022800
Email
hanyan.2006@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25552575
Citation
Arima H, Heeley E, Delcourt C, Hirakawa Y, Wang X, Woodward M, Robinson T, Stapf C, Parsons M, Lavados PM, Huang Y, Wang J, Chalmers J, Anderson CS; INTERACT2 Investigators; INTERACT2 Investigators. Optimal achieved blood pressure in acute intracerebral hemorrhage: INTERACT2. Neurology. 2015 Feb 3;84(5):464-71. doi: 10.1212/WNL.0000000000001205. Epub 2014 Dec 31.
Results Reference
result
PubMed Identifier
30498516
Citation
Cai M, Yu Z, Zhang W, Yang L, Xiang J, Zhang J, Zhang Z, Wu T, Li X, Fu M, Bao X, Yu X, Cai D. Sheng-Di-Da-Huang Decoction Inhibited Inflammation Expressed in Microglia after Intracerebral Hemorrhage in Rats. Evid Based Complement Alternat Med. 2018 Oct 18;2018:6470534. doi: 10.1155/2018/6470534. eCollection 2018.
Results Reference
result
PubMed Identifier
25306400
Citation
Chang JJ, Emanuel BA, Mack WJ, Tsivgoulis G, Alexandrov AV. Matrix metalloproteinase-9: dual role and temporal profile in intracerebral hemorrhage. J Stroke Cerebrovasc Dis. 2014 Nov-Dec;23(10):2498-2505. doi: 10.1016/j.jstrokecerebrovasdis.2014.07.005. Epub 2014 Oct 11.
Results Reference
result
PubMed Identifier
26745705
Citation
Behrouz R, Azarpazhooh MR, Godoy DA, Hoffmann MW, Masotti L, Parry-Jones AR, Popa-Wagner A, Schreuder FH, Slevin MA, Smith CJ, Di Napoli M; MNEMONICH Steering Committee. The Multi-National survey on Epidemiology, Morbidity, and Outcomes iN Intracerebral Haemorrhage (MNEMONICH). Int J Stroke. 2015 Dec;10(8):E86. doi: 10.1111/ijs.12629. No abstract available.
Results Reference
result
PubMed Identifier
30319113
Citation
Cordonnier C, Demchuk A, Ziai W, Anderson CS. Intracerebral haemorrhage: current approaches to acute management. Lancet. 2018 Oct 6;392(10154):1257-1268. doi: 10.1016/S0140-6736(18)31878-6. Erratum In: Lancet. 2019 Feb 2;393(10170):406.
Results Reference
result
PubMed Identifier
24814387
Citation
Ding R, Chen Y, Yang S, Deng X, Fu Z, Feng L, Cai Y, Du M, Zhou Y, Tang Y. Blood-brain barrier disruption induced by hemoglobin in vivo: Involvement of up-regulation of nitric oxide synthase and peroxynitrite formation. Brain Res. 2014 Jul 7;1571:25-38. doi: 10.1016/j.brainres.2014.04.042. Epub 2014 May 9.
Results Reference
result
PubMed Identifier
21169826
Citation
Flower O, Smith M. The acute management of intracerebral hemorrhage. Curr Opin Crit Care. 2011 Apr;17(2):106-14. doi: 10.1097/MCC.0b013e328342f823.
Results Reference
result
PubMed Identifier
30906532
Citation
Garg R, Biller J. Recent advances in spontaneous intracerebral hemorrhage. F1000Res. 2019 Mar 18;8:F1000 Faculty Rev-302. doi: 10.12688/f1000research.16357.1. eCollection 2019.
Results Reference
result
PubMed Identifier
22333136
Citation
Geng X, Ren C, Wang T, Fu P, Luo Y, Liu X, Yan F, Ling F, Jia J, Du H, Ji X, Ding Y. Effect of remote ischemic postconditioning on an intracerebral hemorrhage stroke model in rats. Neurol Res. 2012 Mar;34(2):143-8. doi: 10.1179/1743132811Y.0000000073. Epub 2012 Jan 13.
Results Reference
result
PubMed Identifier
30932784
Citation
Gregson BA, Mitchell P, Mendelow AD. Surgical Decision Making in Brain Hemorrhage. Stroke. 2019 May;50(5):1108-1115. doi: 10.1161/STROKEAHA.118.022694.
Results Reference
result
PubMed Identifier
28081952
Citation
Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, Dawson J, Gandhi D, Ullman N, Mould WA, Mayo SW, Mendelow AD, Gregson B, Butcher K, Vespa P, Wright DW, Kase CS, Carhuapoma JR, Keyl PM, Diener-West M, Muschelli J, Betz JF, Thompson CB, Sugar EA, Yenokyan G, Janis S, John S, Harnof S, Lopez GA, Aldrich EF, Harrigan MR, Ansari S, Jallo J, Caron JL, LeDoux D, Adeoye O, Zuccarello M, Adams HP Jr, Rosenblum M, Thompson RE, Awad IA; CLEAR III Investigators. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017 Feb 11;389(10069):603-611. doi: 10.1016/S0140-6736(16)32410-2. Epub 2017 Jan 10.
Results Reference
result
PubMed Identifier
30739747
Citation
Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7. Erratum In: Lancet. 2019 Apr 20;393(10181):1596.
Results Reference
result
PubMed Identifier
28703081
Citation
Hao S, Wang B. Editorial: Review on Intracerebral Haemorrhage: Multidisciplinary Approaches to the Injury Mechanism Analysis and Therapeutic Strategies. Curr Pharm Des. 2017;23(15):2159-2160. doi: 10.2174/1381612823999170307150448. No abstract available.
Results Reference
result
PubMed Identifier
18480205
Citation
Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534.
Results Reference
result
PubMed Identifier
28628707
Citation
Morotti A, Brouwers HB, Romero JM, Jessel MJ, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Greenberg SM, Martin RH, Qureshi AI, Rosand J, Goldstein JN; Antihypertensive Treatment of Acute Cerebral Hemorrhage II and Neurological Emergencies Treatment Trials Investigators. Intensive Blood Pressure Reduction and Spot Sign in Intracerebral Hemorrhage: A Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2017 Aug 1;74(8):950-960. doi: 10.1001/jamaneurol.2017.1014.
Results Reference
result
PubMed Identifier
19461673
Citation
Rivest S. Regulation of innate immune responses in the brain. Nat Rev Immunol. 2009 Jun;9(6):429-39. doi: 10.1038/nri2565.
Results Reference
result
PubMed Identifier
25693976
Citation
Selim M, Sheth KN. Perihematoma edema: a potential translational target in intracerebral hemorrhage? Transl Stroke Res. 2015 Apr;6(2):104-6. doi: 10.1007/s12975-015-0389-7. Epub 2015 Feb 20. No abstract available.
Results Reference
result
PubMed Identifier
29778325
Citation
Sprigg N, Flaherty K, Appleton JP, Al-Shahi Salman R, Bereczki D, Beridze M, Christensen H, Ciccone A, Collins R, Czlonkowska A, Dineen RA, Duley L, Egea-Guerrero JJ, England TJ, Krishnan K, Laska AC, Law ZK, Ozturk S, Pocock SJ, Roberts I, Robinson TG, Roffe C, Seiffge D, Scutt P, Thanabalan J, Werring D, Whynes D, Bath PM; TICH-2 Investigators. Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial. Lancet. 2018 May 26;391(10135):2107-2115. doi: 10.1016/S0140-6736(18)31033-X. Epub 2018 May 16.
Results Reference
result
PubMed Identifier
25552577
Citation
Toyoda K, Grotta JC. Seeking best medical treatment for hyperacute intracerebral hemorrhage. Neurology. 2015 Feb 3;84(5):444-5. doi: 10.1212/WNL.0000000000001221. Epub 2014 Dec 31. No abstract available.
Results Reference
result
PubMed Identifier
20056489
Citation
van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
Results Reference
result
PubMed Identifier
20713126
Citation
Wang J. Preclinical and clinical research on inflammation after intracerebral hemorrhage. Prog Neurobiol. 2010 Dec;92(4):463-77. doi: 10.1016/j.pneurobio.2010.08.001. Epub 2010 Aug 14.
Results Reference
result

Learn more about this trial

Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

We'll reach out to this number within 24 hrs