| CTRI Number |
CTRI/2024/08/072452 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Rheumatoid arthritis in Ayurveda |
|
Scientific Title of Study
|
A Clinical study to evaluate the combined efficacy of Pippali Paka and Saptamushtika Yusha in the management of Amavata WSR to Rheumatoid Arthritis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manisha Bhati |
| Designation |
Pg scholar |
| Affiliation |
Post Graduate Institute of Ayurveda studies and Research jodhpur rajasthan |
| Address |
PG Scholar Kaya Chikitsa Department Dr Sarvepalli radhakrishnan Rajasthan ayurveda university jodhpur karwad nagaur road
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7610923831 |
| Fax |
|
| Email |
manishabhati065@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brahmanand Sharma |
| Designation |
Associate professor |
| Affiliation |
Post Graduate Institute Of Ayurveda studies and Research Jodhpur Rajasthan |
| Address |
Associate Professor
PG Department of Kayachikitsa Post Graduate Institute of Ayurveda studies and Research DSRRAU Jodhpur Karwad Nagaur road rajasthan india
Jodhpur
RAJASTHAN
324037
India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brahmanand Sharma |
| Designation |
Associate professor |
| Affiliation |
Post Graduate Institute Of Ayurveda studies and Research Jodhpur Rajasthan |
| Address |
Associate Professor
PG Department of Kayachikitsa Post Graduate Institute of Ayurveda studies and Research DSRRAU Jodhpur Karwad Nagaur road rajasthan india
Jodhpur
RAJASTHAN
324037
India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University karwar Jodhpur Rajasthan India Pin code 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Ayurveda Studies and Research Jodhpur |
| Address |
Post Graduate Institute Of Ayurveda Studies and Research Jodhpur Karwad Nagaur road Rajasthan 342037 India |
| 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 Manisha Bhati |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University College Campus Hospital Karwar |
OPD Room No 6
Department of Kayachiktsa
Jodhpur
RAJASTHAN |
7610923831
manishabhati065@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute Of Ayurveda Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: pippali paka , Reference: Yoga ratnakar , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -milk ), Additional Information: -(2) Medicine Name: Saptamushtika Yusha , Reference: Sharangdhar Madhyam khanda , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - medicine will be given in yusha preparation |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. The Patients between the age group of 20 to 70 years in both sexes presenting with clinical features of Amavata.
2. Pre-diagnosed or patient having symptoms of Amavata as mentioned in classical ayurvedic texts.
3. Clinically diagnosed and confirm patients on Amavata.
4. Patients willing to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients of uncontrolled diabetes mellitus, severe anemia, malignancy.
2. Patients having any other severe disease.
3. Pregnant women and lactating mother.
4. Patient below age of 20 & above 70.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in subjective parameter |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Objective Parameters |
45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A CLINICAL STUDY TO EVALUATE THE COMBINED EFFICACY OF PIPPALI PAKA AND SAPTAMUSHTIKA YUSHA IN THE MANAGEMENT OF AMAVATA WSR TO RHEUMATOID ARTHRITIS In this study a single group of total 30 patient of Rheumatoid arthritis will be given Pippali paka and Saptamushtika yusha for 45 days The primary and secondary outcomes will be observed by subjective and objective parameters respectively A single arm study |