| CTRI Number |
CTRI/2022/07/043964 [Registered on: 13/07/2022] Trial Registered Prospectively |
| Last Modified On: |
12/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To see the effect of nirgundi kwath and a herbal formulation in primary osteoarthritis of knee joint |
|
Scientific Title of Study
|
Effect of nirgundi kwath and a herbal formulation in janu sandhigatvata (primary osteoarthritis of knee joint)- A placebo controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lata arya |
| Designation |
MD Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
| Address |
Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
6395353273 |
| Fax |
|
| Email |
aryagunjanlata@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ashwini Nilesh Ingle |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
| Address |
Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9881165320 |
| Fax |
|
| Email |
dr.ashwinifulzele@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Bhushan Sharma |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
| Address |
Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
6395167152 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lata Arya |
Patanjali Ayurveda Hospital |
Department of Kayachikitsa, Opd no. 13
Hardwar
UTTARANCHAL |
6395353273
aryagunjanlata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar PAC/IEC/2022/12 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Orthogrit, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nirgundi Kwath, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient will be selected irrespective of Sex and socio-economic status.
2. Patients have fulfilling criteria for diagnosis of Janu Sandhigatavata such as
Sandhishoola, Sandhishotha, Sparshashatva, Sandhisphutan.
3. Age - 40 to 65 years.
4. Patient with Controlled Diabetes.
5. Patient falling in Grade 1 and Grade 2 of Kellgren–Lawrence radiographic grading scale of osteoarthritis |
|
| ExclusionCriteria |
| Details |
1. Knee Osteoarthritis secondary to other conditions like Trauma, Fractures,
Tuberculosis, malignancy, HIV, Cardiac disease, Neurological disorders, associated
with Janu Sandhigatavata.
2. Patient with total knee joint replacement or complete loss of articular cartilage.
3. Patients having other systemic disorders which might interfere in the present study.
like Amavata (Rheumatoid Arthritis), Gout (Vatarakta), Severe bursitis.
4. Pregnant and lactating women.
5. Patient falling in Grade 3 and 4 of Kellgren–Lawrence radiographic grading scale
of Osteoarthritis. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
X Ray of involved knee joint (Antero Posterior and Lateral View)-
2. Radiography-I To diagnose the patients (at or before day 0) at the time of inclusion.
3. Radiography-II To be compared with Radiography-I at the time of final assessment |
Before intervention of the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
X Ray of involved knee joint (Antero Posterior and Lateral View)-
2. Radiography-I To diagnose the patients (at or before day 0) at the time of inclusion.
3. Radiography-II To be compared with Radiography-I at the time of final assessment |
After intervention at 1 month of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/07/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this trial we are selecting the patients of Primary osteoarthritis of knee in which we will do intervention in two groups (20 patients in each). In one group, we will intervene our ayurvedic preparation(Nirgundi kwath and a herbal formulation tablet) whereas in other group placebo will be given to the patients. Assessment should be done on the basis of assessment done before treatment, during. Follow up and post treatment as discussed earlier. |