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CTRI Number  CTRI/2025/07/091081 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Evaluate Safety and Efficacy of Rumalaya Liniment Roll on. 
Scientific Title of Study   An Open label, Prospective, Single-arm, Multicentric Clinical Study to Evaluate the Safety and Efficacy of Rumalaya Liniment Roll-On in Musculoskeletal conditions. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
HWC/MSCD/PP/013/2025 V1.0, Dated: 4th Jun 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharat Raj R 
Designation  Orthopedic Surgeon 
Affiliation  Mithra-Multi Speciality Hospital  
Address  No 6, SR Layout Kyalasanahalli Village Jigani Town Bommasandra Electronic City Phase I

Bangalore
KARNATAKA
560105
India 
Phone  9686343580  
Fax    
Email  bharathraj.r@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Kumawat 
Designation  Head Of Medical Services and Clinical Development 
Affiliation  Himalaya Wellness Company 
Address  Room No 301, 3rd Floor Medical Services and Clinical Development (R&D) Makali Tumkur Road

Bangalore
KARNATAKA
562162
India 
Phone  8067549904  
Fax    
Email  rajesh.kumawat@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  Dr Soorya Narayan H 
Designation  Manager- Clinical Operations  
Affiliation  Himalaya Wellness Company 
Address  Room No 301, 3rd Floor Medical Services and Clinical Development (R&D) Makali Tumkur road

Bangalore
KARNATAKA
562162
India 
Phone  8067549919  
Fax    
Email  dr.sooryanarayan.h@himalayawellness.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company. Himalaya Welless Company Tumakur Road Makali, Bangaluru 562162 
 
Primary Sponsor  
Name  Himalaya Wellness Company 
Address  Himalaya Welless Company Tumakur Road Makali, Bangaluru 562162 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharath Raj R  Mithra Multi Speciality Hospital.  Neeladri,No 6, SR layout, kyalasanahalli Village Jigani Town, Electronic city Phase 1, Bangalore-560105 Department : Orthopedic Room Number: OPD No.3
Bangalore
KARNATAKA 		 9686343580

bharathraj.r@gmail.com 
Dr Prasad Sorganvi  Sri Laxmi Hospital  #50,opp to velankani road,Doddathoguru,Village,Electronic City,Post,Bangalore-560100. Department: Orthopedic Room Number: OPD No.3
Bangalore
KARNATAKA 		 9880757449

prasad_doct@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ACE independent Ethics Commitee  Approved 
ACE independent Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M628||Other specified disorders of muscle. Ayurveda Condition: MAMSAGATAVATAKOPA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Rumalaya Liniment Roll On , Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: sos, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 14 Days, Reference: NA, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Adult male and female participants aged between18-65 years.
2)Participants presenting with mild to moderate pain (Pain score 1-6 based on VAS (Appendix I)) due to known musculoskeletal conditions like Cervical and lumbar spondylosis, sciatica, carpal tunnel syndrome, tennis elbow, chronic joint pain, joint immobility, chronic muscle pain, Sprains, Strains, etc.
Note: If participants have pain in multiple locations, only one location will be considered for the assessment by the investigator.
3)Participants who have not participated in any other similar clinical study in the last one month.
4)Participants willing to sign informed consent and follow the study procedure.
5)Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, throughout the duration of study participation.
Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
a)Has not undergone a hysterectomy or bilateral oophorectomy; or
b)Has not attained menopause (Women not menstruating for at least 12 consecutive months). 
 
ExclusionCriteria 
Details  1)Participants with severe musculoskeletal conditions (bruises, trauma, muscle damage, raw wounds, fractures, hematoma etc.).
2)Participants who are on any regular pain killers or have used any oral or topical pain killers (NSAIDs, opioid analgesics, steroid medication, muscle relaxant, herbal etc.) in the past 24 hours prior to screening.
3)Participants who are not willing to refrain from using any other similar topical applications during the study period.
4) Any known generalized skin conditions, condition that prevents easy application of the test product (disorders, presence of open wounds etc.).
5)Participants with known clinically significant neurological, respiratory, cardiovascular, gastrointestinal, hepatic, congenital or any other chronic disorder that can interfere with the study conduct in the opinion of the Investigator.
6)Participants with known history or present condition of allergic response to any of the ingredients in the investigational product.
7)Pregnant as assessed by UPT & History of Amenorrhea and lactating women.
8)Known history of drug abuse/dependency that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions, study procedures or follow-up guidelines.
9)Any other conditions (physical, psychological, social or uncontrolled dietary measures) that can interfere with the participant’s compliance to the study in the opinion of the Investigator. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy Endpoints
•Time required for the onset of pain relief
•Time required for next/successive application (lasting pain relief)
•Reduction in pain, swelling, tenderness, redness, muscle stiffness and immobility based on Visual Analogue Scale (VAS).
•Product feedback questionnaire 		 Day 1, Day 5 and Day 14. 
 
Secondary Outcome  
Outcome  TimePoints 
Safety Endpoints
1. General Physical and Vital Signs.
2. Local intolerance (Appendix-II)
3. Adverse event assessment 		 Day 1, Day 5 and Day 14. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   28/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is an open-label, prospective, single-arm, multicentric clinical study designed to evaluate the safety and efficacy of Rumalaya Liniment Roll-On in individuals suffering from various musculoskeletal conditions. The study aims to assess the effectiveness of the product in providing relief from pain, stiffness, and discomfort associated with conditions such as cervical spondylosis, lumbar spondylosis, sciatica, carpal tunnel syndrome, tennis elbow, chronic joint pain, joint immobility, chronic muscle pain, sprains, and strains. Participants will receive Rumalaya Liniment Roll-On as per the recommended application guidelines, and outcomes will be assessed using validated pain and functional scoring tools over a defined treatment period. The study will also monitor adverse events to evaluate the safety profile of the product. The findings will help support the clinical utility of Rumalaya Liniment Roll-On in the management of common musculoskeletal disorders. 
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