| CTRI Number |
CTRI/2010/091/000365 [Registered on: 30/04/2010] |
| Last Modified On: |
04/06/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
Type of Study
Modification(s)
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to assess the efficacy of poly-herbal formulation "NARTANA" in comparison with Diclofenac in patients with mild to moderate oseroarthritis of knees. |
Scientific Title of Study
Modification(s)
|
A Phase III, double blind, randomised, parallel design, controlled clinical study to evaluate the efficacy and safety of poly-herbal formulation "NARTANA" in patients with mild to moderate osteoarthritis of knees. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Milind Modak |
| Designation |
|
| Affiliation |
|
| Address |
Yogesh Hospital, 1188, Sadashiv Peth,
Off. Tilak Road,
Pune
MAHARASHTRA
411030
India |
| Phone |
02024478740 |
| Fax |
|
| Email |
drmilindmodak@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Milind Modak |
| Designation |
|
| Affiliation |
|
| Address |
Yogesh Hospital, 1188, Sadashiv Peth,
Off. Tilak Road,
Pune
MAHARASHTRA
411030
India |
| Phone |
02024478740 |
| Fax |
|
| Email |
drmilindmodak@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Milind Modak |
| Designation |
|
| Affiliation |
|
| Address |
Yogesh Hospital, 1188, Sadashiv Peth,
Off. Tilak Road,
Pune
MAHARASHTRA
411030
India |
| Phone |
02024478740 |
| Fax |
|
| Email |
drmilindmodak@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| M/s Nisarga Biotech Pvt.Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
Nisarga Biotech PvtLtd |
| Address |
275, Chandan Nagar, Adnl. MIDC, SATARA M.S.India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Milind Modak |
Deenanath Mangeshkar Hospital & Research Centre |
Erandwane,,-411004
Pune
MAHARASHTRA |
02040151000
020025420104
research@dmhospital.org |
| Dr.Milind Modak |
Yogesh Hospital |
1188, Sadashive Peth,,Off Tilak Road,-411030
Pune
MAHARASHTRA |
020 24478740
drmilindmodak@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Deenanath Mangesgkar Hospital & Research Centre, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Osteoarthritis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
DICLOFENAC |
50mg tab bid for first 15 days and 100 mg tab.od for next 75 days |
| Intervention |
NARTANA |
450mg capsule bid for first 15 days and 450mg od for 75 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age above 40 years of either sex.
2) Diagnosis of OA in at least one knee joint (ACR classification for knee OA) confirmed by X ray.
3) Subject willing to come for regular follow up visits
4) Subject ready to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Patients who have very severe or doubtful OA diagnosis.
2) Subjects with severe co-morbidities, other known rheumatic conditions, congestive heart failure, Ischemic Heart Disease(IHD) and severe and or uncontrolled Hypertension
3) The patients with current or recent corticosteroid treatment; or ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicines or concurrent pain relieving medication such as antipyretics, analgesics, tranquilizers, hypnoties, excessive alcohol, NSAIDSs.
4) Patients incapacitated or bound to wheel chair or bed and unable to carry out self care activities.
5) History of active peptic ulcer, severe renal, hepatic or hemopoietic disease or severe cardiac insufficiency or undergoing artery bypass graft (CABG) surgery.
6) Non degenerative joint diseases or other joint.
7) Patient with history of known hypersensitivity to Diclofenac.
8) Any condition that, in the opinion of the Investigator,does not justify the patient?s inclusion in the study.
|
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Efficacy of poly-herbal formulation "Nartana" in comparison with Diclofenac |
at visit on day 1,45 & 90 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Safety- Adverse events, serious adverse events, during the subject participation period of 90 days. |
at visit on day 1,45 & 90 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
14/12/2010 |
| Date of Study Completion (India) |
06/09/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Paper titled Efficacy of an Ayurvedic Formulation for mild to moderate Osteoarthritis A Phase 3 Randomized Controlled Study authored by Dr Milind Modak and Dr Mohini Barde has been published in Alternate Therapies Jan Feb 2017 Issue Vol 23 No 1 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A Phase III, double blind, randomised, controlled clinical study is undertaken to evaluate the efficacy & safety of poly-herbal formulation "NARTANA" in 80 patients with mild to moderate oesteoarthritis of knees. The trial shall be conducted at two centres:1)Deenanath Mangeshkar Hospital & Research Centre, Pune & 2)Yogesh Hospital, Pune. The treatment will be given for 3 months. Diclofenac is used as a comparator (active controlled)drug. Efficacy of the drug will be evaluated based on visits on day (-7), 1, 15, 30, 45, 60, 75 & 90. |