Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II
Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)
1 other identifier
interventional
80
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedOctober 19, 2020
October 1, 2020
2.8 years
May 30, 2019
October 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain score 1
Pain score from Visual analog scale
28 day
Secondary Outcomes (1)
Pain score 2
28 day
Study Arms (2)
100 mg SHT extract
EXPERIMENTALDrug: Sahastara remedy alcoholic extract comparison with diclofenac
25 mg dicolfenac
EXPERIMENTALDrug: diclofenac comparison with diclofenac
Interventions
The concentration of SHT extract is 100 mg per capsule
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mr NARIN KAKATUMlead
Study Sites (1)
Mr. NARIN KAKATUM
Bangkok, BKK, 11130, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Associate Professor Arunporn Itharat, Ph.D.
faculty of Medicine, Thammasat University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Faculty of Medicine
Study Record Dates
First Submitted
May 30, 2019
First Posted
October 19, 2020
Study Start
January 1, 2018
Primary Completion
October 13, 2020
Study Completion
October 13, 2020
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share