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CTRI Number  CTRI/2020/02/023199 [Registered on: 07/02/2020] Trial Registered Prospectively
Last Modified On: 09/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Clinical trial of NRL/2019/JC capsules in knee osteoarthritis 
Scientific Title of Study   Evaluation of the efficacy and safety of NRL/2019/JC capsules in knee osteoarthritis: A randomized, double-blind, placebo controlled crossover clinical study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/19-20/009 Ver 1 dated 20th sept 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjit Sisode 
Designation  Consultant 
Affiliation  Janseva Hospital 
Address  Janseva Hospital, 1st floor, OPD 1, Datta Mandir Chowk, Dhule 424001. Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone    
Fax    
Email  manjit.sisode8888@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Omkar Kulkarni 
Designation  Senior Manager, Research and Development 
Affiliation  Netsurf Research Labs Pvt Ltd 
Address  Dept of Research and Development,Office 107, Second floor, Plot 2, Laxman Nagar, Baner Road, Baner, PUNE 411045 (Maharashtra) India.

Pune
MAHARASHTRA
411045
India 
Phone    
Fax    
Email  omkar.kulkarni@nrl.net.in  
 
Details of Contact Person
Public Query  
Name  Dr Omkar Kulkarni 
Designation  Senior Manager, Research and Development 
Affiliation  Netsurf Research Labs Pvt Ltd 
Address  Dept of Research and Development, Office 107, Second floor, Plot 2, Laxman Nagar, Baner Road, Baner, PUNE 411045 (Maharashtra) India.

Pune
MAHARASHTRA
411045
India 
Phone    
Fax    
Email  omkar.kulkarni@nrl.net.in  
 
Source of Monetary or Material Support  
Netsurf Communications Pvt Ltd 
 
Primary Sponsor  
Name  Netsurf Communications Pvt Ltd 
Address  107, Plot 2, Laxman Nagar, Baner Road, Baner, PUNE 411045 (Maharashtra) India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjit Sisode  Janseva Hospital   1st floor, OPD 1, Datta Mandir Chowk, Dhule 424001.
Dhule
MAHARASHTRA 		 9850001222

manjitsisode8888@gmail.com 
Dr Umesh Gajare  Jyoti Multispeciality Clinic  B wing shop 3, Sai Preetam Nagari Apartmnet, Kalewadi, Pune 411017
Pune
MAHARASHTRA 		 9422420986

umeshgajare001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Royal pune independent ethics committee  Approved 
Royal pune independent ethics committee  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  NRL/2019/JC  NRL/2019/JC capsule 1 BD after meals for 90 days 
Comparator Agent  Placebo  Placebo capsules 1 BD after meals for 90 days 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Male and/or female volunteers aged between 40 to 60 years both inclusive.

BMI greater than or equal to 24 Kg/m2 and less than or equal to 38 Kg/m2

Willing to come for regular follow-up visits.

Patients diagnosed with osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria.
 
 
ExclusionCriteria 
Details  Patients with congenital arthropathy, rheumatoid arthritis, active gout, other type of arthritis with/without inflammation e.g. septic , fibromyalgia or collagen vascular disease

Patients with known history of coagulopathies

Osteoarthritis of any other joint except knee

Patients with history of major trauma or surgery in the knee joint

Patients with uncontrolled diabetes and hypertension

Body mass index (BMI) >38 kg/m2.

Patients with any severe cardiac, renal and hepatic disease

Pregnant and lactating women

Patients who participated in any clinical trial within 30 days before enrollment into the study

Any other condition which the Principal Investigator thinks may jeopardize the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Pain, stiffness and difficulty in movement by WOMAC score between the groups.

Physicians global Assessment of performance of patient on pain VAS scale

Improvement in SF-36 Health Survey score

Levels of inflammatory mediators CRP, IL-6, TNF-alpha

Symptom improvement like morning stiffness, tiredness, tenderness, and muscle spasms
 		 Screening day, Baseline Day, Day 30, 60 and 90. 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of subjects with reduced doses of NSAID

Drug compliance

Global assessment for overall improvement

Tolerability of study drugs

Adverse events/ Adverse drug reactions

Vitals like pulse, body temperature, rate of respiration.

Changes in biochemical parameters like, CBC, KFT, LFT and Urine routine etc.
 		 Screening day, Baseline Day, Day 30, 60 and 90. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 1/ Phase 2 
Date of First Enrollment (India)   11/02/2020 
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="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Osteoarthritis (OA) is a long-term chronic disease characterized by the deterioration of cartilage in joints which results in bones rubbing together and creating stiffness, pain, and impaired movement. The disease most commonly affects the joints in the knees, hands, feet, and spine and is relatively common in shoulder and hip joints. While OA is related to ageing, it is also associated with a variety of both modifiable and no modifiable risk factors, including: obesity, lack of exercise, genetic predisposition, bone density, occupational injury, trauma, and gender. The prevalence of OA is increasing due to population ageing and an increase in related factors such as obesity. 
In this study clinical crossover study of NRL/2019/JC capsules  with placebo is planned to validate polyherbal formulation in management of knee osteoarthritis.
 
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