| CTRI Number |
CTRI/2024/08/072381 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Nithya Virechana In The Patients Of Rheumatoid Arthritis |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Effect Of Nithya
Virechana On Range Of Movements In Amavata w s r 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 Deeksha Nayaka H V |
| Designation |
PG Scholar (Panchakarma) |
| Affiliation |
Rajiv Gandhi University Of Health Sciences,Bengaluru |
| Address |
OPD 9,Department Of Panchakarma,Shri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital ,Kuthpady, Udupi ,Karnataka
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9901789300 |
| Fax |
574118 |
| Email |
dikshv1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath kanthi |
| Designation |
BAMS MD (AYU) Assistant professor Department of Panchakarma |
| Affiliation |
Rajiv Gandhi University Of Health Sciences,Bengaluru |
| Address |
OPD 9 ,Department Of Panchakarma,Shri Dharmasthala Manjunnatheshwara College Of Ayurveda And Hospital, Kuthpady, Udupi
574118
Karnataka
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9844469138 |
| Fax |
574118 |
| Email |
kanthipk03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeksha Nayaka H V |
| Designation |
PG Scholar (Panchakarma) |
| Affiliation |
Rajiv Gandhi University Of Health Sciences,Bengaluru |
| Address |
OPD 9 , Department Of Panchakarma, Shri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital , Kuthpady,Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9901789300 |
| Fax |
574118 |
| Email |
dikshv1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara Ayurveda Pharmacy , Laxminarayana Nagar P.O.Kuthpady-574118 Udupi , Karnataka, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Deeksha Nayaka H V |
Shri Dharmasthala Manjunatheshwara Ayurveda Hospital kuthpady Udupi |
Department of Panchakarma ,OPD 9 Panchakarma, Udupi , Karnataka
Udupi
KARNATAKA |
9901789300
dikshv1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committe - Human |
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, (2) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, (3) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gandharvahastadi erandam, Reference: Bhaishajya rathnavali, Route: Oral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: Gandharvahastadi eranda taila about 25 - 30 ml with ushna jala was given for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling diagnostic criteria of Rheumatoid arthritis/Amavata
Patients aged between 35-60 years
Patients who are fit for Nithya virechana karma |
|
| ExclusionCriteria |
| Details |
Patients with systemic illness like Diabetes Mellitus Hypertension which will hamper the treatment
Pregnancy and Lactating women
All autoimmune disorder other than Rheumatoid arthritis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in stiffness , Pain
Changes in visual Analogue Scale,Chronic Pain Grade Scale
|
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in all other symptoms of Rheumatoid Arthritis like pain , swelling , joint stiffness |
7 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)
|
20/08/2024 |
| 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="2"
Months="0"
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 current study will be on A Clinical Study to evaluate the effect of Nithya Virechana In Range Of movements in Amavata w s r to Rheumatoid arthritis.In this study minimum of 30 diagnosed case of Amavata w s r to Rheumatoid arthritis will be selected from Shri Dharmasthala Manjunatheshwara Ayurveda Hospital Kuthpady Udupi Karnataka India . The patient will be administered Gandharvahastadi Earanda taila in empty stomach, in a dose of 25 -30ml with ushna jala as anupana at 9 am for 7 days . The range of movements is assessed through Goniometer Visual Analogue Scale Chronic pain grade Scale UCLA Shoulder Rating scale RAPID 3 Score HAQ-DI. |