| CTRI Number |
CTRI/2024/11/076126 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Low digestive fire in cause and pathogenesis of rheumatoid arthritis and its comparative study by Rasonadi Kashaya and Kulattha Yusha. |
|
Scientific Title of Study
|
Role of Agnimandya in Nidana Evum Samprati of Amavata with special reference to rheumatoid arthritis and its comparative Upshayatmaka Parikshana by Rasonadi Kashaya and Kulattha Yusha. |
| 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 Joshi Sonal Ram |
| Designation |
M.D. Scholar |
| Affiliation |
Government Ayurvedic P.G.College And Hospital Chaukaghat Varanasi |
| Address |
Department Of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic P.G. College And Hospital,Chaukaghat,Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9637940997 |
| Fax |
|
| Email |
sonalmehkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avadhesh Kumar |
| Designation |
Professor and H.O.D PG department of Roga Nidana Evum Vikriti Vigyana |
| Affiliation |
Government Ayurvedic PG College And Hospital Chaukaghat Varanasi |
| Address |
Department Of Roga Nidana Evum Vikriti Vigyana Government
Ayurvedic P.G. College And Hospital,Chaukaghat,Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9455262663 |
| Fax |
|
| Email |
dravadheshsaroj@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joshi Sonal Ram |
| Designation |
M.D. Scholar |
| Affiliation |
Government Ayurvedic P.G. College And Hospital Chaukaghat Varanasi |
| Address |
Department Of Roga Nidana Evum Vikriti Vigyana Government
Ayurvedic P.G. College And Hospital,Chaukaghat,Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9637940997 |
| Fax |
|
| Email |
sonalmehkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic P.G. College And Hospital Chaukaghat
Varanasi,Uttar Pradesh,221002,India |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic P G College And Hospital Chaukaghat Varanasi |
| Address |
Department Of Roga Nidana Evum Vikriti Vigyana Government P.G. Ayurvedic P G College And Hospital,Chaukaghat,Varanasi.Uttar Pradesh,221002 |
| 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 Joshi Sonal Ram |
Government Ayurvedic P G College And Hospital, Varanasi. |
OPD No.10 of Department of Roga Nidana Evum Vikriti Vigyana, Government P G Ayurvedic College And Hospital, Chaukaghat.
Varanasi
UTTAR PRADESH |
9637940997
sonalmehkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government PG Ayurveda College and Hospital, Varanasi, U.P Mahayogi Guru Gorakhnath Ayush University, Gorakhapur, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasonadi Kashaya, Reference: Bhaishajya Ratnavali( Amavata Chikitsaprakarana 29/23), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kulattha Yusha, Reference: Vangasena (Amavata Chikitsa 27/22), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshnjala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having sign and symptoms of Amavata will considered for the present study.
2) Patients of 16-60 years of age.
3) Patients of either sex.
4) Patient either married and unmarried.
5) Chronicity of less than 10 years.
6) Patient who has satisfied the criteria laid down by the American Rheumatisın Association will be selected and registered for detailed investigation and follow up Patient has to satisfied atleast 4 of these 7 criteria. |
|
| ExclusionCriteria |
| Details |
1) Complicated cases of R.A, associated with DM & HTÎ.
2) Patients suffering from Carcinoma, Systemic diseases like- Chronic Renal disease, Heart/Hepatic disease, HIV & other immune compromised diseases.
3) Pregnant and lactating mothers.
4) Severe deformities with severe ankylosed joints, Patients of R.A with chronicity of more than 10 years.
5) Patients below 16 years and above 60 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rasonadi kashaya and kulattha yusha help in relieving the Symptoms of agnimandya and also in symptoms of Amavata . |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant relief in symptoms of amavata and also any adverse events experienced by participants.
It also helps in improving the quality of life in amavata patients. |
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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="1"
Months="6"
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
|
Objective: To compare the effectiveness of Rasonadi kashaya and Kulattha yusha in treating Amavata and investigate the role of Agnimandya in the disease process.
Participants: 60 Adults diagnosed with Amavata meeting inclusion and exclusion criteria from OPD and IPD of department of Rog nidan Evum Vikriti Vigyana and Department of Kayachikitsa of Government PG Ayurvedic Medical College and Hospital Chaukaghat, Varanasi.
Interventions:
30 patients -Rasonadi Kashaya: Administered according to a standardized protocol.
30 patients - Kulattha Yusha: Administered according to a standardized protocol.
Primary Outcome: 1)Rasonadi kashaya and kulattha yusha help in relieving the Symptoms of agnimandya and also in symptoms of Amavata .
Secondary Outcomes:1)Significant relief in symptoms of amavata and also any adverse events experienced by participants. 2)It also helps in improving the quality of life in amavata patients. Follow up -15 Days
Time Period: 1 month
Data Analysis: Data will be analyzed using appropriate statistical methods to compare the effectiveness of the interventions on the primary and secondary outcomes.
Ethical Considerations: The study will be conducted in accordance with ethical guidelines and with informed consent from participants. |