A Clinical Study on the Effectiveness of Zandu Rhumasyl Maxx Ayurvedic Liniment for Joint and Muscle Pain Relief

Phase 2

Not yet recruiting

• Conditions: Primary osteoarthritis of other joints. Ayurveda Condition: SANDHIGATAVATAH,

• Registration Number: CTRI/2025/04/084564
• Lead Sponsor: Emami Ltd

Brief Summary

The potential participants who are willing to provide a written informed consent form will be asked to come for screening. The main inclusion criteria of the screening procedure will be an NRS score (at rest) of 4 or above. Onset of Analgesia, PRS & McGill –SFQ will also be taken at the screening which will be considered as the baseline score. The subjects will be asked specific history of pain like date of occurence, time of onset, duration of pain, part of the body affected, history of similar pain in the past (<24h, 24-48h, >48h), its severity, duration of pain, any treatment taken etc. Any underlying condition which will affect the current pain or evaluation of treatment will be sought for and excluded by history and physical examination. The participants will then be allocated to receive topical treatment of (IP) **Zandu Rhumasyl Maxx** for 15 days and on the day of scheduled visits (day1, day 7 and day 15) post dose for every 30 minutes’ interval up to 6hrs the participant will be asked to indicate their resting pain intensity, onset of analgesia, pain relief, and also their pain on movement using the NRS and PRS scale.  The investigator will also measure the pain on application of pressure using the NRS. McGill-SF questionnaire will be taken at all interventional visits and at the end of the study to evaluate quality of pain. A subject will remain on study until 15 days. Subjects who discontinue (IP) Zandu Rhumasyl Maxx before week 2 will be followed for 7 days after the last dose of (IP) Zandu Rhumasyl Maxx and then complete the end-of-study visit. The clinical site team will evaluate the safety data throughout the study, including an initial safety review after the first 15 subjects have received at least 1 application of (IP) Zandu Rhumasyl Maxx.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-25
• Last Update Posted: 2025-10-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Adult subject, Male or female between 18-65 years of age.
• 2.A score of 5cm or above on the NRS (at rest) 3.Subjects having Acute Musculoskeletal Pain e.g. musculoskeletal injuries (pain & inflammation), muscle cramps & symptoms associated with conditions such as osteoarthritis, sport injury, sprain, back pain, leg cramps, sciatica, frozen shoulder and spondylitis, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 sprain or strain), not requiring admittance to hospital.
• 4.Willing to give voluntary informed consent.

Exclusion Criteria

• 1.Subject with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management.
• painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles.
• Subjects with Grade 2 & 3 sprain or strain.
• 2.Subjects with known history of rheumatoid arthritis.
• 3.Subjects with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
• 4.Subjects with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action.
• 5.Subjects underlying dermatitis or dermatosis associated with the injury.
• 6.Use of any oral or topical analgesic, antipyretic, sedative, anti-inflammatory, muscle relaxants or any other oral or topical medications which in the opinion of the investigator would influence the conduct and outcomes of the study.
• 7.Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation.
• 8.Any kind of neuralgic pain, headache and/or chronic pain 9.Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies.
• 10.A known pregnancy or lactation 11.Previous history of gastro-intestinal hemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding.
• 12.Subjects who are severe smokers and drinkers 13.Received an investigational or product or participated in an investigational study within a period of 30 days prior to receiving study medication.
• 14.Scheduled elective surgery or other invasive procedures during the period of study participation.
• 15.Subjects with a history of diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases an active infectious disease (HBV, HCV, HIV) which in the opinion of the investigator would influence the conduct and outcomes of the study.
• 16.A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.NRS (at rest) SPID6 (Sum of Pain intensity difference)	[ Time Frame: day 1, day 7 and day 15]

Secondary Outcome Measures

Name	Time	Method
1.Earliest onset of analgesia	2.NRS (on movement) SPID6 (Sum of Pain intensity difference)

Trial Locations

Locations (1)

Saveetha Medical College and Hospital SIMATS; 🇮🇳 Chennai, TAMIL NADU, India

Saveetha Medical College and Hospital SIMATS

🇮🇳Chennai, TAMIL NADU, India

Dr Navin Balasubramanian

Principal investigator

09710929393

drnavin_ortho@yahoo.co.in