Clinical Trial of Three Different Topical Formulations in arthritis of Knee(s) and Backache.

A Randomized, Single blind, Prospective, Multi-center, Phase II, Clinical Study to Evaluate Efficacy and Safety of Three Different Topical Formulations in Subjects Suffering from Osteoarthritis of Knee(s) and Backache. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/03/006714

Enrollment

180

Registered

2016-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Osteoarthritis of Knee(s) and Backache

Interventions

Intervention1: AY 94: AY 94: Peppermint (Menthol), Karpura, Yavani, Gandhapura tel, Eucalyptus oil, Sallai Guggul, Lavang tel, Rosmary oil, Sunthi, Capsaicin, Atasi ka Tel. Dosage and Treatment Durat

Eligibility

Inclusion criteria

Inclusion criteria: •Pain in one or both knee joints due to OA for a minimum of six months and maximum for five years •Low Back Pain without any serious medical/surgical condition for a minimum period of six months. •History of knee pain or Low Back Pain requiring the use of NSAIDs Acetaminophen, or another analgesic agent on a regular basis for at least six months before the screening visit •OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s) •Subjects not having knee or severe Lumbar joint deformity •Subjects signing written informed consent and ready to comply with the protocol requirement •Subjects with pain VAS greater than 40 mm on weight bearing activities

Exclusion criteria

Exclusion criteria: •Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease •Use of any analgesics except the study medication or paracetamol •Use of systemic corticosteroids within 2 months of screening, or intraarticular viscosupplementation within the past 3 months •Use of any other investigational drug within 1 month prior to randomization •Subjects having uncontrolled diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease •Known other active and serious medical or surgical disease •Pregnancy and Lactation. •Known hypersensitivity to ingredients used in study drug.

Design outcomes

Primary

Measure	Time frame
1). Assessment of Knee Joint Pain and Backache on VAS 2). Assessment of Knee Joint pain on WOMAC Index 3) Assessment of Back ache Bournemouth questionnaire Timepoint: Day 7, Day 14, Day 21, Day 28	—

Secondary

Measure	Time frame
1. Time of onset of action as counter irritation and in relieving painful symptoms 2. Intensity of the study drugs as a counter-irritant and in relieving painful symptoms 3. Duration of effect the study drugs as a counter irritant 4. Requirement of rescue medicines 5. Time taken to walk a distance of 50 feet 6. Global assessment for overall improvement by the investigator 7. Quality of life on SF 36 questionnaire 8. Assessment of comparative safetyTimepoint: Day 7, Day 14, Day 21, Day 28	—

Measure

Time frame

1. Time of onset of action as counter irritation and in relieving painful symptoms 2. Intensity of the study drugs as a counter-irritant and in relieving painful symptoms 3. Duration of effect the study drugs as a counter irritant 4. Requirement of rescue medicines 5. Time taken to walk a distance of 50 feet 6. Global assessment for overall improvement by the investigator 7. Quality of life on SF 36 questionnaire 8. Assessment of comparative safetyTimepoint: Day 7, Day 14, Day 21, Day 28

—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026