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A COMPARATIVE STUDY ON EFFICACY AND SAFETY OF RTSABYUGS (FORMULA FROM BHUTAN) VERSUS DICLOFENAC FOR RELIEVING KNEE PAIN IN PRIMARY OSTEOARTHRITIS PATIENTS

A COMPARATIVE STUDY ON EFFICACY AND SAFETY OF RTSABYUGS (FORMULA FROM BHUTAN) VERSUS DICLOFENAC FOR RELIEVING KNEE PAIN IN PRIMARY OSTEOARTHRITIS PATIENTS

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190623001
Enrollment
Unknown
Registered
2019-06-23
Start date
2019-06-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis patient with acute knee pain. OA&#44

Interventions

Oil extract from Curcuma longa&#44
Carum carvi&#44
Myristica fragrans&#44
Delphinium brunonianum&#44
Cautleya spicata and Sesamum indicum and patient will be advice to massage with oil and diclofenac gel over anterior and exterior part of knee for three times a day (morning&#44
afternon & evening for 20 minutes) continues for 7 days from the baseline and applicable for the control and placebo group to follow the same procedure as mentioned., Topical nonsteroidal anti&#45
inflammatory drugs (NSAIDs) can be alternative treatment to oral pain killers that can relieve symdromatic knee OA pain. The efficacy of topical diclofenac sodium 1% gel (DSG) for symptomatic knee OA
12 weeks of topical DSG showed significantly larger scale of reductions in WOMAC pain (52.6% vs 43.1%
p=0.008) and physical function (49.7% vs 39.4%
P = 0.004) versus vehicle and provided significant improvements in most secondary endpoints (H. S B Basaf et al 2010).
Placebo Comparator Drug,Active Comparator Drug
rTsabyugs,Diclofenac gel

Sponsors

Thammasat University
Lead Sponsor
Thammasat University
Collaborator

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: a) Both male and female&#44; age group between 45&#45;75years old b) Body mass index (BMI) < 25 kg/m2 c) The symptoms of OA must have mild to moderate according to the index of severity for OA of the knee. d) Participants with minimum visual analog scale (VAS) score 4&#45;6 e) Good communication and cooperation. f) Participants should not under go any medication before 2 weeks of enrollment in the research. g) Participants oriented to the risks and benefits of the research and willing to sign the consent form.

Exclusion criteria

Exclusion criteria: a) Participants using any topical application during investigation. b) Patient undergone lower extremity surgery in the past 6 months. c) Conditions of erythema&#44; edema and with open wound on the knee. d) Women with pregnancy or breast feeding. e) Participants having allergic to herbs such as; Ccurcuma longa&#44; Myristica fragrans&#44; Carum curvi&#44; Delphnium brununium&#44; Catleya spicata and Plai. f) If the subject plan to admit for surgery or move to other places during the study.

Design outcomes

Primary

MeasureTime frame
efficacy of oil in knee pain patients 2 months Knee injury and osteoarthritis outcome scores

Secondary

MeasureTime frame
Quality of life 2 months &#44; Visual Analog Scale&#44; Knee range of Motion&#44; Quality of life

Countries

Thailand

Contacts

Public ContactDorji Nidup

Thammasat University

drungtsho2005@gmail.com0950109047

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026