| CTRI Number |
CTRI/2024/06/069512 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Purgation with misraka sneha in treating rheumatoid arthritis |
|
Scientific Title of Study
|
clinical study on Virechana karma with Misraka sneha in the management of Amavata. |
| 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 Sindhoora V Prabhu |
| Designation |
Second year PG scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of ayurveda and Hospital |
| Address |
Department of Panchakarma
Shri Dharmasthala Manjunatheshwara college of ayurveda and Hospital
BM road
Thanniruhalla
Hassan
Pin 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8197479442 |
| Fax |
|
| Email |
prabhusindhu1512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sindhoora V Prabhu |
| Designation |
Second year PG scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM road
Thanniruhalla
Hassan
Pin 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8197479442 |
| Fax |
|
| Email |
prabhusindhu1512@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Lohith B A |
| Designation |
Associate professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM road
Thanniruhalla
Hassan
PIN 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM road
Thanniruhalla
Hassan
Pin 573201
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
DrSindhoora V Prabhu |
| Address |
Department of Panchakarma
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM road
Thanniruhalla
Hassan
Pin 573201 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sindhoora V Prabhu |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
Department of Panchakarma
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM road
Thanniruhalla
Hassan 573201
Hassan
KARNATAKA |
8197479442
prabhusindhu1512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka |
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 | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: CHARAKA SAMHITA, Procedure details: Poorva karma includes
1)Deepana - Pachana by Chitrakadi
Vati and Panchakola phanta till nirama lakshanas.
2)Snehapana is given with panchatiktaka guggulu ghrita.
3)Visrama kala -Sarvanaga abhyanga with brihat saindhavadi taila followed by bashpa
sweda.
Pradhana karma includes
1)Sarvanga abhyanga with murchita tila taila26 followed by bashpa sweda.
2)Virechana with Misrakasneham 15ml,Anupana-honey
Paschat karma includes
1)washing of hands, feet and face.
2)Samsarjana karma)
(1) Medicine Name: MISRAKA SNEHA, Reference: ASTANGA HRIDAYA, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Participants full fill the diagnostic criteria aged between 20 to 60 years of either gender.
-Participants with lakshanas of amavata14.
-Participants indicated for virechana.
-Participants with diabetes mellitus and hypertension under control.
-Participants with madhyama kosta. |
|
| ExclusionCriteria |
| Details |
-Participants diagnosed with other inflammatory and degenerative joint diseases.
-Pregnant and Lactating woman.
-Participants with Amavata presenting with complication including joint deformities.
-Any other condition interfering the course of treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| whether the given medicine is effective in causing proper purgation (samyak virikta lakshanas) |
On the day of purgation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.RHEUMATOID FACTOR
2.C-REACTIVE PROTEIN
3.JOINT TENDERNESS
4.VAS SCORE |
24days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/07/2024 |
| 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
|
Name of the Department-Department of Panchakarma
Name of the Student- Dr. Sindhoora V Prabhu
Name of the Guide- Dr. Lohith B A
Title of the Study-Clinical Study on Virechana Karma With Misraka Sneha In The Management Of Amavata
Virechana is a Karma, where doshas are expelled out of body through gudamarga. Misrakasneha is one of the formulation explained in gulma chikitsa adhyaya of Ashtanga Hridaya, where it has been used for Sramsana in gulma rogi. It contains Eranda taila, Ghrita and Ksheera along with pippali, amalaka, draksha and shyamadigana dravyas.Though it is mentioned in Gulma chikitsa, it is similar to amruta for all types of Vatavyadhi. Misrakasneha is rarely used medicine for virechana when compared to other sneha yogas.Utility of Misrakasneha is not explored much yet. Based on the ingredients it may be effective in minimal dosage to produce Samyak Virikta lakshanas as compared to other yogas. Amavata is the disease affecting Asthi and Sandhis wherein Ama and Vata are the initiating factors in the pathogenesis.Being contradictory in nature poses difficulty in planning the line of treatment. Due to wide spectrum of disease ,much prevalence in the society the disease is being chosen for the study. In Amavata chikitsa Sutra , Virechana is also one of the treatment. Chakradatta has emphasized specially about virechana which we can understand by the simile of Eranda taila as Gajakesari Taking the above background into consideration, it was thought worthwhile to evaluate the efficacy of Misrakasneha for Virechana in the management of Amavata. |