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Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II

Sponsor
Mr NARIN KAKATUM (Other)
Overall Status
Recruiting
CT.gov ID
NCT04591795
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
33.4
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Oct 13, 2020
Anticipated Study Completion Date :
Oct 13, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 100 mg SHT extract

Drug: Sahastara remedy alcoholic extract comparison with diclofenac

Drug: Diclofenac
Diclofenac sodium, 25 mg enteric-coated tablets
Experimental: 25 mg dicolfenac

Drug: diclofenac comparison with diclofenac

Drug: Sahastara remedy extract
The concentration of SHT extract is 100 mg per capsule
Other Names:
  • SHT extract

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain score 1 [28 day]

      Pain score from Visual analog scale

    Secondary Outcome Measures

    1. Pain score 2 [28 day]

      Pain score from Modified WOMAC score (from Modified Thai WOMAC index)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mr. NARIN KAKATUM Bangkok BKK Thailand 11130

    Sponsors and Collaborators

    • Mr NARIN KAKATUM

    Investigators

    • Study Director: Associate Professor Arunporn Itharat, Ph.D., faculty of Medicine, Thammasat University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mr NARIN KAKATUM, Faculty of Medicine, Thammasat University
    ClinicalTrials.gov Identifier:
    NCT04591795
    Other Study ID Numbers:
    • MTU-EC-TM-2-116_2/59
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mr NARIN KAKATUM, Faculty of Medicine, Thammasat University
    Sahastara
    Osteoarthritis
    Herbal Medicine
    Additional relevant MeSH terms:
    Osteoarthritis
    Diclofenac

    Study Results

    No Results Posted as of Oct 19, 2020