Back to resultsSahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Sahastara remedy extract
Diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Sahastara, Osteoarthritis, Herbal Medicine
Eligibility Criteria
Inclusion Criteria:
- No pregnancy
- No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
- No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study
Exclusion Criteria:
- Uncontrolled Hypertension (BP>140/90 mm.Hg.) BMI > 30
- Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
- On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline
Sites / Locations
- Mr. NARIN KAKATUMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
100 mg SHT extract
25 mg dicolfenac
Arm Description
Drug: Sahastara remedy alcoholic extract comparison with diclofenac
Drug: diclofenac comparison with diclofenac
Outcomes
Primary Outcome Measures
Pain score 1
Pain score from Visual analog scale
Secondary Outcome Measures
Pain score 2
Pain score from Modified WOMAC score (from Modified Thai WOMAC index)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04591795
Brief Title
Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II
Official Title
Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 13, 2020 (Actual)
Study Completion Date
October 13, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mr NARIN KAKATUM
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
To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II).
Detailed Description
Sample size 66 volunteers
The patients were divided randomly into 2 treatment groups. The patients in group 1 received the SHT extract 300 mg/day (1 capsule of 100 mg SHT extract three times daily before meals). The patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). In addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of Gastrointestinal adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Sahastara, Osteoarthritis, Herbal Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
100 mg SHT extract
Arm Type
Experimental
Arm Description
Drug: Sahastara remedy alcoholic extract comparison with diclofenac
Arm Title
25 mg dicolfenac
Arm Type
Experimental
Arm Description
Drug: diclofenac comparison with diclofenac
Intervention Type
Drug
Intervention Name(s)
Sahastara remedy extract
Other Intervention Name(s)
SHT extract
Intervention Description
The concentration of SHT extract is 100 mg per capsule
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
Diclofenac sodium, 25 mg enteric-coated tablets
Primary Outcome Measure Information:
Title
Pain score 1
Description
Pain score from Visual analog scale
Time Frame
28 day
Secondary Outcome Measure Information:
Title
Pain score 2
Description
Pain score from Modified WOMAC score (from Modified Thai WOMAC index)
Time Frame
28 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No pregnancy
No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study
Exclusion Criteria:
Uncontrolled Hypertension (BP>140/90 mm.Hg.) BMI > 30
Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mr.NARIN KAKATUM
Phone
0667867161
Email
narin.ka@ssru.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Associate Professor Arunporn Itharat
Phone
0667867161
Email
iarunporn@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Associate Professor Arunporn Itharat, Ph.D.
Organizational Affiliation
faculty of Medicine, Thammasat University
Official's Role
Study Director
Facility Information:
Facility Name
Mr. NARIN KAKATUM
City
Bangkok
State/Province
BKK
ZIP/Postal Code
11130
Country
Thailand
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II
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