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CTRI Number  CTRI/2024/07/070163 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study of nutritional formulations in the management of knee osteoarthritis. 
Scientific Title of Study   A randomized, double-blind, parallel-group, comparative, multicenter, placebo-controlled clinical trial to assess the efficacy & safety of nutritional formulations in the management of knee osteoarthritis. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
LS/24-25/001 Version 1.00 dated 1 June 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  Fourth floor OPD 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, Pashan-Sus road, Mohan nagar, 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, Pashan-Sus road, Mohan nagar, 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  Fourth Floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 9766400243
-
amolgothwad01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee 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  Group A: LSOA01 capsules.   Group A: LSOA01 one capsule twice a day for 90 days.  
Intervention  Group B: LSOA02 capsules.  Group B: LSOA02 one capsule twice a day for 90 days. 
Comparator Agent  Group C: Placebo capsules.  Group C: Placebo one capsule twice a day for 90 days. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of either sex with age 40 to 65 years (both inclusive) with a BMI not more than 30.00 kg/m2; 2.Confirmed diagnosis of knee osteoarthritis as per clinical American College of Rheumatology (ACR) criteria – Clinical OA of the knee is defined as knee pain and at least three out of six of the following criteria: age greater than 50 years, morning stiffness less than 30 min, crepitus, bony tenderness, bony enlargement, and no palpable warmth; 3.Patients with a minimum pain visual analog scale (VAS) score greater than 4 on walking in one or both knees during the 24 hrs. preceding recruitment; 4.Patient 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.Patients taking analgesics ready for the washout period of at least 3 days (or longer depending on the pharmacokinetic of drug) before starting the study intervention. 6.Patients willing to come for regular follow up visits; 7.Participants can walk and give both verbal and written information regarding the study. 
 
ExclusionCriteria 
Details  1.Known history of hypersensitivity to herbal extracts or dietary supplements;
2.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test;
3.Non-degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of OA (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection);
4.Patients incapacitated or bound to a wheelchair or bed and unable to carry out self-care activities;
5.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine;
6.Evidence of several renal, hepatic, or hematopoietic diseases or severe cardiac insufficiency as revealed by laboratory investigations;
7.Patient with congestive heart failure;
8.Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 3 months;
9.Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months;
10.Indication of surgery for OA knee;
11.Arthroscopy of either knee in the past year;
12.Any condition that in the opinion of the investigator does not justify the patient’s inclusion in 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.Changes in 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.Changes in VAS pain scale score. 		 From Screening to the end of the study. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in biomarkers such as PIIANP, Human Procollagen 2 C-terminal Peptide, COMP, Urinary C-Telopeptide of type II collagen (CTX-II), TNF-Alpha, IL-6, hs-CRP, MMP 3.
2.Changes in requirement of analgesic as a rescue medication.
3.Changes in gastrointestinal symptoms like heartburn, gastric discomfort, and epigastric pain on the 4-point Linkert scale.
4.Changes in KOOS scoring for quality of life.
5.Changes in symptom grading on a 4-point Linkert scale for joint swelling, tenderness, and warmth.
6.Changes in distance covered in the six‐minute walk test
 		 From Screening to the end of the study. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   15/07/2024 
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="6"
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   OA is a highly prevalent chronic joint disease that leads to significant pain, disability, and loss of function, particularly in the knees. Pharmacological treatments for OA primarily focus on symptom relief and often come with adverse effects, such as gastrointestinal and cardiovascular issues. There is a growing need for safer, more effective treatments that not only alleviate symptoms but also address the underlying pathophysiology of OA.
This study aims to fill this gap by evaluating the effects of nutritional formulation on pain, stiffness, and mobility in participants with knee OA over 90 days. 
The study’s design includes comprehensive assessments of both primary and secondary endpoints. These include changes in WOMAC scores, VAS pain scale, six-minute walk test, inflammatory biomarkers, and reliance on analgesics. Additionally, safety will be rigorously monitored through adverse event profiling and hematological and biochemical evaluations. 
The results could offer a new, nutritional option for OA patients, potentially improving their quality of life while minimizing the risks associated with conventional treatments.
 
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