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CTRI Number  CTRI/2023/02/049625 [Registered on: 10/02/2023] Trial Registered Prospectively
Last Modified On: 28/10/2023
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 trial of Re-Cart capsules in knee osteoarthritis 
Scientific Title of Study   Randomized, double blind, placebo controlled clinical study to assess the efficacy & safety of Re-Cart capsules in subjects with knee osteoarthritis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/22-23/011 Version 1.0 dated 10 January 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V G Vaidya 
Designation  Managing Trustee 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Forth floor OPD 401 314 B Telco Road Chinchwad Pune MAHARASHTRA India

Pune
MAHARASHTRA
411033
India 
Phone  9822057766  
Fax  -  
Email  vgvclinical@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Ganu 
Designation  Managing Director  
Affiliation  Mprex Healthcare Pvt. Ltd 
Address  Fifth Floor 501 514 Crossroad Bhumkar sqaure Wakad Pune

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  gayatri.mbgindia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashi Shekhar Kumar 
Designation  President- International Business 
Affiliation  Cachet Pharmaceuticals Pvt.Ltd 
Address  Fourth Floor, international market department 415 Shah Nahar, Dr. E.Moses Road, Worli MUMBAI

Mumbai
MAHARASHTRA
400018
India 
Phone  022-40829999  
Fax  -  
Email  SHASHI.SHEKHAR@CACHETPHARMA.COM  
 
Source of Monetary or Material Support  
CACHET PHARMACEUTICALS PVT.LTD 415 SHAH NAHAR, DR. E.MOSES ROAD, WORLI MUMBAI 400018 
 
Primary Sponsor  
Name  Cachet Pharmaceuticals Pvt.Ltd 
Address  415 Shah Nahar, Dr. E.Moses Road, Worli MUMBAI 400018 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Ashish Suryawanshi  Lokmanya Medical Research Centre and Hospital  Forth floor OPD 401 314 B Telco Road Chinchwad Pune
Pune
MAHARASHTRA 		 8010347452
-
lmrc.ortho@gmail.com 
 
Details of Ethics Committee
Modification(s)  
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 
Comparator Agent  Placebo capsules  One capsule twice a day for 90 days 
Intervention  Re-Cart capsules  One capsule twice a day for 90 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adults (age 18 to 60) both sex with BMI not more than 30.00 kg/m2;
2.Confirmed Diagnosis of knee osteoarthritis as per ACR (American College of Rheumatology)
3.Patient reported pain score between 5-15 (Both inclusive) on WOMAC-A scale at screening. 
 
ExclusionCriteria 
Details  1.Conditions such as rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease as per clinical judgement or available evidences and laboratory findings with patients;
2.BMI >30 kg/m2;
3.Indication of surgery for OA knee;
4.Arthroscopy of either knee in the past year;
5.Use of systemic steroids or herbal medication for OA within 4 weeks of screening;
6.Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months;
7.Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months;
8.History of osteoporotic/ osteoarthritic fractures within the past 6 months;
9.Pregnant or lactating women or women with inadequate contraceptive measures;
10.Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction);
11.Presence of any clinically significant laboratory anomaly;
12.Moderate to severe peripheral neuropathy or other neurological disorders;
13.Alcohol abuse, medication or drug dependence. 
 
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 at baseline, day 30, 60 and end of the study.
WOMAC-A is assessed by a Linkert 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. Knee Range of Motion (ROM) results measured by goniometer at baseline and end of the study.
3. Symptom grading on 4-point Linkert scale for joint swelling, tenderness, warmth at baseline to end of the study. 		 Screening, Baseline, Day 30, Day 60 and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
1.Kellgren Lawrence radiological severity of Grade at baseline and end of the study.
2.CRP and Il-6 levels at baseline and end of the study.
3.Requirement of analgesic as a rescue medication at baseline, day 30, 60 and end of the study.
4.Changes in gastrointestinal symptoms like heartburn, gastric discomfort, epigastric pain on 4 point Linkert scale.
5.KOOS scoring for quality of life at baseline and end of the study.
6.FACIT-F score at baseline and end of the study. 		 Screening, Baseline, Day 30, Day 60 and Day 90 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   13/02/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Randomized, double blind, placebo controlled clinical study to assess the efficacy & safety of Re-Cart capsules in subjects with knee osteoarthritis. 
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