| CTRI Number |
CTRI/2025/11/096773 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use and effect of Vriddhadarvadya Lauha In Amavata Rheumatoid arthritis |
|
Scientific Title of Study
|
Pharmaceutico analytical study and clinical efficacy of Vriddhadarvadya lauha in 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 Ankita Kumawat |
| Designation |
PG Scholar RSBK |
| Affiliation |
Madan Mohan Malviya Goverment Ayurveda College Udaipur |
| Address |
Department of Rasshastra And Bhaishajya Kalpana MMM Goverment Ayurveda College Udaipur Udaipur RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
9057272663 |
| Fax |
|
| Email |
ankitakumawat422@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Department of Rasshastra And Bhaishajya Kalpana MMM Goverment Ayurveda College Udaipur Udaipur RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413257535 |
| Fax |
|
| Email |
sharmadrajay@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Department of Rasshastra And Bhaishajya Kalpana MMM Goverment Ayurveda College Udaipur Udaipur RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413257535 |
| Fax |
|
| Email |
sharmadrajay@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Ambamata Udaipur Rajasthan Pincode 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College Ambamata Udaipur Rajasthan Pincode 313001 |
| Type of Sponsor |
Government medical college |
|
|
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 Ankita Kumawat |
Madan Mohan Malviya Government Ayurved College Udaipur |
OPD No:2 PG Department of Rasashastra and Bhaishajya kalpana Udaipur RAJASTHAN
Udaipur
RAJASTHAN |
9057272663
ankitakumawat422@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMM. Goverment Ayurved College Udaipur |
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: Vriddhadarvadya Lauha, Reference: Rasendra Chintamani chapter no 25 shloka 94, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Amavata signs and symptoms morning stiffness tenderness and swelling of joints ete
Results of lab tests showing RA factor and CRP test
Patients between the ages of 20 yrs to 70 yrs |
|
| ExclusionCriteria |
| Details |
Patients having severe deformity and complications
patients suffering from serious illnesses like cancer chronic liver failure etc
Pregnant and lactating women
A patient with any drug sensitivity
Patients age below 20 yrs and above 70 yrs |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in RA factor and CRP reading |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RA factor and CRP will be assessed |
15 days,30 days & 45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
03/03/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is A Pharmaceutico - Analytical Study And Clinical Efficacy of Vriddhadarvadya Lauha in Amavata wsr to Rheumatoid arthritis . There will be 2 groups in the study, In Group A randomly selected and clinically diagnosed 30 patients of Amavata whose RA Factor and CRP will be high than normal range.Group A will be given prepared Vriddhadarvadya Lauha as per classical method and 30 patients of Group B randomly selected and clinically diagnosed will be placebo group. Trial will be conduct for a period of 2 months. Follow up of the case will be after every 15 days that is 4 times during treatment. Final assessment will be done after completion of 2 months course on the basis of subjective, objective and laboratoral assessment. The data will be analyzed scientifically and statistically. |