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CTRI Number  CTRI/2024/10/074997 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Topical pain relief oil]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study of pain relief oils in patients with osteoarthritis. 
Scientific Title of Study   A parallel arm clinical study to evaluate the efficacy and safety of pain relief oils in patients with osteoarthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/032 Version: 1.00 Dated: 23-August-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amol Gothwad 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  OPD Fourth floor 401 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  9766400243  
Fax  -  
Email  amolgothwad01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishnavi Patil 
Designation  Project Coordinator 
Affiliation  Life Synergy 
Address  Office no 503, Orbisoul 46 Downtown,Mohan nagar, Pashan-Sus road, Baner

Pune
MAHARASHTRA
411045
India 
Phone  9834585994  
Fax  -  
Email  vaishnavilifesynergy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishnavi Patil 
Designation  Project Coordinator 
Affiliation  Life Synergy 
Address  Office no 503, Orbisoul 46 Downtown, Mohan nagar, Pashan-Sus road, Baner

Pune
MAHARASHTRA
411045
India 
Phone  9834585994  
Fax  -  
Email  vaishnavilifesynergy@gmail.com  
 
Source of Monetary or Material Support  
Life Synergy office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner, Pune 411045, Maharashtra. 
 
Primary Sponsor  
Name  Life Synergy 
Address  office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner, Pune 411045, Maharashtra. 
Type of Sponsor  Other [[Nutraceutical product promoter]] 
 
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 Amol Gothwad  Lokmanya Medical Research Centre and Hospital  OPD Fourth Floor 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 09766400243
-
amolgothwad01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LS/PO/01  Apply a sufficient amount of oil on both knees with a gentle massage twice a day for 60 days. 
Intervention  LS/PO/02  Apply a sufficient amount of oil on both knees with a gentle massage twice a day for 60 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants meeting all the following criteria will be eligible for the study: 1. Adults aged 45 to 65 years (both inclusive), of both sexes, with a Body Mass Index (BMI) not more than 30.00 kg per meter square; 2. Clinical diagnosis of osteoarthritis of the knee based on clinical evaluation and or radiographic evidence; 3. Participants with a pain visual analog scale (VAS) score between 1-7 (mild-moderate) preceding recruitment; 4. Participant ambulant and requiring treatment with an anti inflammatory drug and not receiving regular anti inflammatory or analgesic drugs or not satisfied with drugs being taken and seek a change; 5. Participants willing to come for regular follow up visits and provide data of the analgesic consumption during study period; 6. Participants can walk and give both verbal and written information regarding the study. 
 
ExclusionCriteria 
Details  Participants meeting any of the following criteria will not be eligible for the study:
1. Participants incapacitated or bound to wheelchair or bed and unable to carry out self-care activities;
2. Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study;
3. Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine;
4. Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months;
5. Indication of surgery for OA knee;
6. Arthroscopy of either knee in the past year;
7. Any condition that in the opinion of the investigator does not justify the participant’s inclusion for the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. WOMAC A, B, and C subscale scores for pain, stiffness and physical disability. WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain, WOMAC- B for levels of stiffness and WOMAC-C for levels of physical disability
2. VAS pain scale score
3. Knee range of motion (ROM) measured by goniometer
4. Symptom grading on a 4-point Linkert scale for joint swelling, tenderness, and warmth 		 1. Baseline, day 15, 30, day 60
2. Screening, baseline, day 15, 30, day 60
3. Screening and day 60
4. Baseline, day 15, 30, day 60 
 
Secondary Outcome  
Outcome  TimePoints 
1. Adverse events profile
2. Tolerability of the investigational product
 		 From baseline to day 60. 
 
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 
Date of First Enrollment (India)   20/10/2024 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Pain relief oils are commonly used in the management of osteoarthritis (OA) to alleviate pain and reduce inflammation. These oils often contain natural ingredients with anti-inflammatory and analgesic properties. When applied topically, they provide relief by promoting circulation, reducing muscle stiffness, and soothing joint discomfort. This oils, may also stimulate nerve endings, reducing pain perception. While effective for mild to moderate pain, they are typically used as part of a broader pain management plan in osteoarthritis treatment. 
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