| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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.
)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Oil | Apply 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. |