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A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tianshu capsule
Sugar pill
Sponsored by
Jiangsu Kanion Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Tianshu capsule

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must meet the Migraine diagnosis.
  • Age of onset should be before age 50 years.
  • Migraine must have been occurring for 1 year preceding entry into the trial.
  • The number of migraine attack should be no less than 6 for a period of 3 months prior to Screening stage.
  • The number of migraine days is to be 2-8 for a period of 1 month prior to screening for entry into the trial.
  • Migraine days should be less than 15 for a period of 1 month prior to screening for entry into the trial.
  • Ages 18-65.
  • Participant can understand and complete the Headache diary.
  • All participants signed the informed consent.

Exclusion Criteria:

  • Other migraine prophylactic medication is continued 3 months prior to the drug trial.
  • Participants who have taken Tianshu capsule during 1 month prior to Screening stage.
  • The number of acute treatment for migraine is more than 10 per month.
  • Participants who have taken antipsychotics or antidepressant medications (unless only for migraine prophylaxis) during the previous 3 months.
  • Participants who abuse alcohol or other drugs.
  • Participants who are resistant to all acute migraine drugs prescribed optimally.
  • hypotension or uncontrolled hypertension.
  • Severe infections.
  • Malignancy.
  • Significant medical history of such as cardiac disease, cerebrovascular disease, liver disease, nephropathy etc.
  • Known allergies or serious side effects with Tianshu capsule in the past.
  • Breastfeeding, pregnant and potentially fertile women participant.
  • History of cluster headaches, tension-type headache, vascular headache with non-migraine, drug - dependence headache.
  • Secondary headaches, including hypertension, post-traumatic brain syndrome etc.
  • Participants who have taken migraine prophylactic medication regularly during 1 month prior to Screening stage.
  • Participants who are taking part in other clinical trials.

Sites / Locations

  • The People's Hospital,Huaibei
  • Chinese PLA General Hospital
  • Daxing hospital of Traditional Chinese Medicine
  • Quanzhou First Hospita
  • SanMing First Hospital
  • The People's Hospital,Cangzhou
  • Langfang hospital of Traditional Chinese Medicine
  • The two six zero hospital of Chinese people's Liberation Army
  • Tangshan TCM Hospital
  • Kaifeng hospital of Traditional Chinese Medicine
  • Luohe hospital of Traditional Chinese Medicine
  • Wuhan sixth hospital
  • Yiyang central hospital
  • The Affiliated Hospital of Changchun University of Chinese medicine
  • Jilin brain hospital
  • Jinan hospital of traditional Chinese Medicine
  • The second affiliated hospital of Shandong Traditional Chinese Medicine University
  • Affiliated Hospital of Jining Medical University
  • Jining First Hospital
  • Xi An Hospital of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tianshu capsule

Sugar pill

Arm Description

Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks.

Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks.

Outcomes

Primary Outcome Measures

Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline

Secondary Outcome Measures

Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline.
Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline.
Change in the days using acute therapy of Migraine Per 4 weeks at Week 16 from baseline.
Proportion of subjects whose number or days of migraine attacks reduce at least 50%.
Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline.
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, and clinical laboratory tests.
Adverse event reports will be assessed at 0, 4w, 8w, 12w, 16w. clinical laboratory tests including WBC, RBC, HGB, PLT, LEU, ERY, PRO,Stool routine, ALT, AST, TBil, ALP, GGT, BUN, Cr will be assessed at 0, 12w. Electrocardiogram will be assessed at 0, 12w. Vital sign measurements will be assessed at -4w, 0, 4w, 8w, 12w, 16w.

Full Information

First Posted
January 10, 2014
Last Updated
April 13, 2016
Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02035111
Brief Title
A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.
Official Title
To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache.
Detailed Description
Primary headache disorders,particularly migraine is globally prevalent. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs. The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache. To provide a safe and effective treatment of Migraine Headache.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Tianshu capsule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
947 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tianshu capsule
Arm Type
Experimental
Arm Description
Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Tianshu capsule
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Primary Outcome Measure Information:
Title
Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline
Time Frame
-4w,0,4w,8w,12w,16w
Secondary Outcome Measure Information:
Title
Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline.
Time Frame
-4w,0,4w,8w,12w,16w
Title
Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline.
Time Frame
-4w,0,4w,8w,12w,16w
Title
Change in the days using acute therapy of Migraine Per 4 weeks at Week 16 from baseline.
Time Frame
-4w,0,4w,8w,12w,16w
Title
Proportion of subjects whose number or days of migraine attacks reduce at least 50%.
Time Frame
-4w,0,4w,8w,12w,16w
Title
Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline.
Time Frame
-4w,0,4w,8w,12w,16w
Title
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, and clinical laboratory tests.
Description
Adverse event reports will be assessed at 0, 4w, 8w, 12w, 16w. clinical laboratory tests including WBC, RBC, HGB, PLT, LEU, ERY, PRO,Stool routine, ALT, AST, TBil, ALP, GGT, BUN, Cr will be assessed at 0, 12w. Electrocardiogram will be assessed at 0, 12w. Vital sign measurements will be assessed at -4w, 0, 4w, 8w, 12w, 16w.
Time Frame
0, 12w

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must meet the Migraine diagnosis. Age of onset should be before age 50 years. Migraine must have been occurring for 1 year preceding entry into the trial. The number of migraine attack should be no less than 6 for a period of 3 months prior to Screening stage. The number of migraine days is to be 2-8 for a period of 1 month prior to screening for entry into the trial. Migraine days should be less than 15 for a period of 1 month prior to screening for entry into the trial. Ages 18-65. Participant can understand and complete the Headache diary. All participants signed the informed consent. Exclusion Criteria: Other migraine prophylactic medication is continued 3 months prior to the drug trial. Participants who have taken Tianshu capsule during 1 month prior to Screening stage. The number of acute treatment for migraine is more than 10 per month. Participants who have taken antipsychotics or antidepressant medications (unless only for migraine prophylaxis) during the previous 3 months. Participants who abuse alcohol or other drugs. Participants who are resistant to all acute migraine drugs prescribed optimally. hypotension or uncontrolled hypertension. Severe infections. Malignancy. Significant medical history of such as cardiac disease, cerebrovascular disease, liver disease, nephropathy etc. Known allergies or serious side effects with Tianshu capsule in the past. Breastfeeding, pregnant and potentially fertile women participant. History of cluster headaches, tension-type headache, vascular headache with non-migraine, drug - dependence headache. Secondary headaches, including hypertension, post-traumatic brain syndrome etc. Participants who have taken migraine prophylactic medication regularly during 1 month prior to Screening stage. Participants who are taking part in other clinical trials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengyuan Yu
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The People's Hospital,Huaibei
City
Huaibei
State/Province
Anhui
ZIP/Postal Code
235000
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Daxing hospital of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102600
Country
China
Facility Name
Quanzhou First Hospita
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362002
Country
China
Facility Name
SanMing First Hospital
City
Sanming
State/Province
Fujian
ZIP/Postal Code
365000
Country
China
Facility Name
The People's Hospital,Cangzhou
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061000
Country
China
Facility Name
Langfang hospital of Traditional Chinese Medicine
City
Langfang
State/Province
Hebei
ZIP/Postal Code
065000
Country
China
Facility Name
The two six zero hospital of Chinese people's Liberation Army
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Tangshan TCM Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
Kaifeng hospital of Traditional Chinese Medicine
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
475000
Country
China
Facility Name
Luohe hospital of Traditional Chinese Medicine
City
Luohe
State/Province
Henan
ZIP/Postal Code
462000
Country
China
Facility Name
Wuhan sixth hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Yiyang central hospital
City
Yiyang
State/Province
Hunan
ZIP/Postal Code
413000
Country
China
Facility Name
The Affiliated Hospital of Changchun University of Chinese medicine
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130117
Country
China
Facility Name
Jilin brain hospital
City
Siping
State/Province
Jilin
ZIP/Postal Code
136000
Country
China
Facility Name
Jinan hospital of traditional Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Name
The second affiliated hospital of Shandong Traditional Chinese Medicine University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Facility Name
Jining First Hospital
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Facility Name
Xi An Hospital of Traditional Chinese Medicine
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31842860
Citation
Yu S, Ran Y, Xiao W, Tang W, Zhao J, Chen W, Zhuang H, Ouyang C, Lin H, Liu D, Chen T, Huang H, Wang B, Hao Y, Yan Z, Zhao S, Wang Y, Ni J, Wang C, Ding W, Li G, Cao J, Tian S. Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial. BMC Complement Altern Med. 2019 Dec 16;19(1):370. doi: 10.1186/s12906-019-2775-2.
Results Reference
derived

Learn more about this trial

A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.

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