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CTRI Number  CTRI/2026/03/105726 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 02/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To relieve acute muscle and bone pain with GS/CM/RR/O-1 
Scientific Title of Study   A randomized placebo controlled trial to evaluate analgesic and anti inflammatory effects for Musculo skeletal disorders. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GS-RRBMO-2025-01 Version No. 1.0; Date: 20-09-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gangothri S Kumar 
Designation  Research Consultant 
Affiliation  Greenspace 
Address  Unit no. 0401N, 4th floor, Beacon tower-2,Brigade Twin Towers, No. 11/1-4, Jai Bharath Industries Pipeline Road,Yeshwanthpur

Bangalore
KARNATAKA
560022
India 
Phone  7795525107  
Fax    
Email  dr.gangothri@greenspaceherbs.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gangothri S Kumar 
Designation  Research Consultant 
Affiliation  Greenspace 
Address  Unit no. 0401N, 4th floor, Beacon tower-2,Brigade Twin Towers, No. 11/1-4, Jai Bharath Industries Pipeline Road,Yeshwanthpur

Bangalore
KARNATAKA
560022
India 
Phone  7795525107  
Fax    
Email  dr.gangothri@greenspaceherbs.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gangothri S Kumar 
Designation  Research Consultant 
Affiliation  Greenspace 
Address  Unit no. 0401N, 4th floor, Beacon tower-2,Brigade Twin Towers, No. 11/1-4, Jai Bharath Industries Pipeline Road,Yeshwanthpur

Bangalore
KARNATAKA
560022
India 
Phone  7795525107  
Fax    
Email  dr.gangothri@greenspaceherbs.com  
 
Source of Monetary or Material Support  
Dr. Utsa Basu’s Clinic, 65A, Middle Road (Phillips More), Entally, Kolkata – 100014, India  
Greenspace, #16 Sharma complex, 1st Cross, Pampa Extension, Kempapura, Hebbal, Bengaluru, Karnataka 560024, India 
 
Primary Sponsor  
Name  Greenspace 
Address  Unit No. 0401N, 4th Floor, No. 11/1-4, Beacon Tower-2, BRIGADE TWIN TOWERS, Jai Bharath Industries Pipeline Road, Yeshwanthpur, Bengaluru – 560022 
Type of Sponsor  Other [Nutraceuticals] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Utsa Basu  Dr. Utsa Basu’s Clinic  Dept. of Gen. Medicine, Room no. 1, 65A, Middle Road (Phillips More), Entally, Kolkata – 100014
Kolkata
WEST BENGAL 
9432658968

dr.utsabasu@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinimed Independent Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Ashtanga Hridaya- Sutra sthana- 2/8, Procedure details: Apply GS/CM/RR/O-1 twice a day (Morning & evening) to the affected area for 15 consecutive days. )
2Comparator Arm (Non Ayurveda)-Placebo OilApply the placebo oil twice a day (Morning and evening) to the affected area for 15 consecutive days.
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Subjects of both genders with age group between 15-85 years
2. Subjects with Musculo-skeletal pain due to idiopathic, systemic or trauma for more than 24 hours.
3. Pain of VAS scale between 5-44mm (Mild pain) to 45-74 mm (Moderate pain)
4. Subjects who are willing to give written consent.

 
 
ExclusionCriteria 
Details  1.Subjects suffering from co-morbidities like rheumatoid arthritis, gouty arthritis or psoriatic arthritis.
2.Participants with the history of fracture of the joint.
3.Subjects under cortico-steroids, NSAIDS or systemic analgesics.
4.Subjects with gross disability having difficulty performing their routine chores.
5.Hypersensitive to any of the ingredients of the product.
6.Open wounds or injury at the site of application of oil.
7.Any other condition which the investigator feels will jeopardize the trial.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Change in pain intensity measured through Visual Analogue Scale (VAS) scale from baseline to 15 days.
2.Change in functional ability measured through Brief Pain Inventory questionnaire (BPI) from baseline to 15 days.

3.Average time taken for reducing the pain and duration of effectiveness of the oil.
 
Day 0, Day 8 and Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in swelling, tenderness or stiffness as per gradation (if present)
2. Change in PEG (Pain, enjoyment, general activity) tool from baseline to 15 days
3. Improvement in sleep from baseline to 15 days
4. Any changes in pigmentation if present
5. Local adverse events (redness, itching, burning)/ tolerability of the product
6. Serious adverse events
 
Day 0 and Day 15 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   20/03/2026 
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="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Musculo-skeletal pain is one of the major public health issues prevailing globally; they cause long term pain leading to physical disabilities, reducing the ability to work and decreasing the quality of life of the people and becoming a heavy burden in terms of cost to the individual. It encompasses a wide spectrum of disorders from simple ligament injury, sprain to various complicated issues involving the skeletal structure. Lower back pain and osteoarthritis are the most common problems related to Musculo-skeletal disorders. Among the elderly patients, Musculo-skeletal pain is highly prevalent with rates between 40-60%. It is not confined to a single joint, but its multi-site involvement contributes significantly to disability among elderly patients.

In a healthy individual, pain is defined as a complex sensory experience associated with actual or potential tissue damage. Pharmacological treatments include oral and topical analgesics like non-steroidal anti-inflammatory drugs (NSAIDS), paracetamol, tramadol and opioids. While these pain killers can have serious side effects when taken on a longer run, topical agents can achieve a similar efficacy without the involvement of systemic effects. Various herbs and essential oils are mentioned in Ayurvedic treatises and numerous research studies on phytoconstituents have demonstrated analgesic effects of topical application. Based on literature review, an oil blend to relieve pain and stress was developed by Greenspace. The current study intends to assess its efficacy, safety and tolerability in different types of acute and chronic pain conditions.

 
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