| CTRI Number |
CTRI/2024/10/075221 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the efficacy of vedanasthapana mahakashaya parisheka on pain parameter in condition of rheumatoid arthritis |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the effect of vedanasthapana mahakashaya parisheka on pain parameter 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 Nidhi Nirmal |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8168352600 |
| Fax |
|
| Email |
dr.nidhinirmal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niranjan Rao |
| Designation |
BAMS MD(AYU) Professor and HOD Department of Panchakarma |
| Affiliation |
Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448835203 |
| Fax |
|
| Email |
rao.drniranjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Nirmal |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8168352600 |
| Fax |
|
| Email |
dr.nidhinirmal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharamasthala Manjunatheshwara Ayurveda Pharmacy Kuthpady Udupi Karnataka India - 574118 |
|
|
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 Nidhi Nirmal |
Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi
Udupi
KARNATAKA |
8168352600
dr.nidhinirmal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharamsthala Manjunatheshwara College of Ayurveda Udupi 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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Cakradatta Chapter 25/1-2, Procedure details: Vedanasthapana Mahakashaya Parisheka to whole body without abhyanga will be done for 30 minutes once a day for 7 days. The temperature will be maintained between 38-42 degree celsius.)
(1) Medicine Name: Vedanasthapana Mahakshaya, Reference: Charak Samhita Sutrasthana 4/47, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 10000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Cakradatta Chapter 25/1-2, Procedure details: Twak Patra Parisheka to whole body without abhyanga will be done for 30 minutes once a day for 7 days. the temperature will be maintained between 38-42 degree celsius.)
(1) Medicine Name: Twak Patra, Reference: Susuruta Samhita Sutrasthana 38/24, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 10000(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Freshly diagnosed cases of rheumatoid arthritis with positive RA factor
2. Patients fit for parisheka swedana |
|
| ExclusionCriteria |
| Details |
1. Patients with systemic illness like uncontrolled diabetes mellitus, hypertension
2. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome will be assessed based on the following parameters
Subjective Parameters
Pain, Visual Analogue Scale, Verbal Rating Scale, Numerical Rating Scale, painDETECT,Symptoms of Rheumatoid Arthritis
Objective Parameters
RA factor, CRP, ESR |
0th day, 07th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
0th day and 14th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="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
|
This is a randomized, open labelled, parallel group study comparing the efficacy of Controlled group - A , Twak Patra Parisheka which will be given to whole body without abhyanga once in a day for 7 days and the Trial group - B, Vedanasthapana Mahakashaya Parisheka which will be given to whole body without abhyanga once in a day for 7 days for 15 patients to each group and selection will be based on permuted block randomization method. The study will be conducted in Sri Dharamasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi. The primary outcome measures will be assessed by subjective and objective parameters. The secondary outcome measures will be assessed based on the quality of life scale. Hence this study is an effort to prove the efficacy of Vedanasthapana Mahakashaya Parisheka on pain parameter of Amavata w. s.r. to Rheumatoid Arthritis.
|