| CTRI Number |
CTRI/2019/06/019881 [Registered on: 26/06/2019] Trial Registered Prospectively |
| Last Modified On: |
05/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical trial for safety and efficacy of grassroots leads in the management of Osteoarthritis of knee joints. |
|
Scientific Title of Study
|
A randomized controlled single blind clinical trial for safety and efficacy of grassroots leads in the management of Osteoarthritis of knee joints. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Room no.2,Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,India
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Room no.2,Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,India
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kshipra Rajoria |
| Designation |
Lecturer |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Room no.6,Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,Rajasthan,India
Jaipur
RAJASTHAN
302004
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
|
Source of Monetary or Material Support
|
| National innovation foundation,Grambharti,Amrapur road,Amrapur,Gandhinagar,Gujrat,Pin-328650,India |
|
|
Primary Sponsor
|
| Name |
National innovation foundation |
| Address |
National innovation foundation,Grambharti,Amrapur, Gandhinagar,Gujrat,India |
| Type of Sponsor |
Research institution |
|
|
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 Sarvesh Kumar Singh |
Madhav Vilas Hospital, National Institute of Ayurveda,Jaipur, |
Room no.2,Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,India
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
8739860237
sarveshksingh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee National institute of Ayurveda Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1-Standard Ayurvedic drug |
Lakshadi Guggulu 500 mg twitce a day,orally, after meal for 12 weeks |
| Intervention |
Group 10 – NIF herbal grassroots lead 2 formulation 2 |
NIF herbal grassroots lead 2 formulation 2 in higher dose for 12 weeks |
| Comparator Agent |
Group 2 – Standard Allopathic drug |
Acetominophen in a dose of 650 mg thrice a day, orally,after meal for 12 weeks
|
| Intervention |
Group 3 - NIF herbal grassroots lead 1 formulation 1 |
NIF herbal grassroots lead 1 formulation 1 in lower dose for 12 weeks |
| Intervention |
Group 4 – NIF herbal grassroots lead 1 formulation 1 |
NIF herbal grassroots lead 1 formulation 1 in higher dose for 12 weeks |
| Intervention |
Group 5 – NIF herbal grassroots lead 1 formulation 2 |
NIF herbal grassroots lead 1 formulation 2 in lower dose for 12 weeks |
| Intervention |
Group 6 – NIF herbal grassroots lead 1 formulation 2 |
NIF herbal grassroots lead 1 formulation 2 in higher dose for 12 weeks |
| Intervention |
Group 7 - NIF herbal grassroots lead 2 formulation 1 |
NIF herbal grassroots lead 2 formulation 1 in lower dose for 12 weeks |
| Intervention |
Group 8 – NIF herbal grassroots lead 2 formulation 1 |
NIF herbal grassroots lead 2 formulation 1 in higher dose for 12 weeks |
| Intervention |
Group 9 – NIF herbal grassroots lead 2 formulation 2 |
NIF herbal grassroots lead 2 formulation 2 in lower dose for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Primary Osteoarthritis – knee joints (single or both knees)
2. Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II to IV) that is not older than 6 months prior to the date of screening
3. Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 5-point Likert Pain Subscale) assessed at screening
4. Moderate to moderately-severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks prior to screening, have been/are being used)
5. No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure
6. No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).
|
|
| ExclusionCriteria |
| Details |
1. Patient with history of hypersensitivity to any drugs.
2. Presence of tense effusions
3. Patients with Pott’s spine/infections/other systemic diseases
4. Patients with systemic conditions such as Gouty Arthritis, Rheumatoid Arthritis Psoriatic Arthritis, SLE.
5. Patients with Diabetes/Hypertension
6. Bed ridden patients
7. Chondromalacia
8. Any other disease or condition interfering with the free use and evaluation of the index
knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis)
9. Major injury to the index knee within the 12 months prior to screening
10. Severe hip osteoarthritis ipsilateral to the index knee.
11. Any pain that could interfere with the assessment of index knee pain (e.g. pain in any
other part of the lower extremities, pain radiating to the knee)
12. Any pharmacological or non-pharmacological treatment targeting OA started or changed
during the 4 weeks prior to randomization or likely to be changed during the duration of the study
13. Patients with metallic implants.
14. History of bony or soft tissue injury to knee joint.
15. No human albumin treatment in the 3 months before randomization or throughout the
duration of the study.
16.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy and safety of Grassroots leads with Ayurvedic drug (Lakshadi Guggulu) and Allopathic drug(Acetominophen) in subject with Osteoarthritis of knee joints |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean changes from baseline in Patient’s Global Assessment of response to therapy |
12 weeks |
| Mean changes from baseline in Physician’s Global Assessment of response to therapy. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
25/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This randomized multi arm controlled,single blind clinical trial will be done for safety and efficacy of two grassroots leads in the management of osteoarthritis of knee joints. Two grassroots leads in two different formulation and in two different doses will be compared against standard Ayurvedic drugs and standard allopathic drug. Each group will be given 12 week of medication and trial will be completed in three years |