| CTRI Number |
CTRI/2024/08/072730 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Panchakarma therapy along with herbal decoction used in treatment of Mamsagata vata |
|
Scientific Title of Study
|
An Open Label Comparative Clinical Study On Virechana Karma And Patra Pinda Sweda Followed By Vishwadi Dwadashanga Kwatha In The Management Of Mamsagata Vata W.S.R. To Fibromyalgia |
| 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 GOVIND NARAYAN |
| Designation |
PhD Scholar |
| Affiliation |
Shri Krishna AYUSH University Kurukshetra Haryana 136118 |
| Address |
OPD No 2 Dept of Panchkarma
Shri Shirdi Sai Baba Ayurveda College and Hospital Mundiyagarh Kishangarh Renwal
Jaipur
RAJASTHAN
303603
India |
| Phone |
07737477174 |
| Fax |
|
| Email |
govindnarayan1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Mehta |
| Designation |
Professor and Head |
| Affiliation |
Shri Krishna Ayush University |
| Address |
Room no 21 Department Of Panchakarma Shri Krishna Ayush University Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8950375285 |
| Fax |
|
| Email |
drashishhmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Govind Narayan |
| Designation |
PhD Scholar Department Of Panchakarma |
| Affiliation |
Shri Krishna Ayush University Kurukshetra Haryana 136118 |
| Address |
Room no 5 Shri Shirdi Sai Baba Ayurveda College And Hospital Mundiyagarh Kishangarh Renwal
Jaipur
RAJASTHAN
303603
India |
| Phone |
07737477174 |
| Fax |
|
| Email |
govindnarayan1988@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
shri shridi sai baba ayurveda college and hospital kishangarh renwal 303603 |
| Type of Sponsor |
Other [self financer] |
|
|
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 GOVIND NARAYAN |
Shri Shirdi Sai Baba Ayurveda College and Hospital |
Room no 5 Mundiyagarh Kishangarh Renwal 303603
Jaipur
RAJASTHAN |
7737477174
govindnarayan1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shri Krishna Ayush University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M797||Fibromyalgia. Ayurveda Condition: MAMSAGATAVATAKOPA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak samhita Siddhi sthan, Procedure details: Virechana will be conducted as per standard protocol & Virechana Yoga will be
given according to Koshtha on empty stomach at 9-10 am.
2. Patra Pinda Sweda will be carried out in accordance with standard procedure for a
15-day for local application.
3. Viswadi Dwadashanga Kwatha as Shamana Chikitsa for 15 days.)
(1) Medicine Name: Trivrutta avaleha , Reference: Charak samhita kalpa sthan 7/24, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 50(g), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm | Procedure | - | Patra pinda swedan | (Procedure Reference: Arogya kalpa drum, Procedure details: Fresh leaves should be cleaned and chopped finely. First
add 50 ml of prescribed oil into frying pan, to this add grated coconut & sliced lemon and fry
till it turns to light-tinged brown. Add chopped leaves one by one; first add drugs which have
thick leaves followed by thin. Then mix thoroughly and fry together till coconut scrapings
attain a brown colored should be divided into two equal parts and made into 2 pottalis
(Average weight of a standard pottali is 300-350 gm).
Treatment period – 15 days
Method of administration of Viswadi Dwadashanga Kwatha- Oral route
Dosage for Viswadi Dwadashanga Kwatha – 20 gm B.D. (Morning and Evening) Before
Meal.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the clinical features of Mamsagata Vata
Patients with the clinical features of Fibromyalgia
Patients fit for Virechana Karma
Chronicity less than ten years
FIQ Score should be less then thirty three
|
|
| ExclusionCriteria |
| Details |
Patient suffering from any chronic debilitating disease like TB Varicose vein Asthma Rheumatoid Arthritis and other chronic problems et cetera and having other serious pathology
Patients suffering from systemic disorders as cardiac problem Diabetes Mellitus Hypertension more than 140mmHg Systolic pressure and diastolic pressure more than 90 mmHg Paralysis Malignancy HIV HBsAg Leprosy
Pregnant women and lactating mother
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any change and improvement present in Mamsagata Vata symptoms of registered patients |
42 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement and change present symptoms in fibromyalgia
Changes in FIBROMYALGIA IMPACT QUESTIONNAIRE
|
48 weeks |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
11/09/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Hypothesis Research Hypothesis There is effect of Virechana Karma and Patra Pinda Sweda Vishwadi Dwadasanga Kwatha in the management of Mamsagata Vata with special reference to Fibromyalgia Null Hypothesis There is no effect of Virechana Karma and Patra Pinda Sweda Vishwadi Dwadasanga Kwatha in the management of Mamsagata Vata with special reference to Fibromyalgia Aim of study To compare the effect of Virechana Karma and Patra Pinda Sweda Followed by Viswadi Dwadashanga Kwatha in the management of Mamsagata Vata with special reference to Fibromyalgia Objectives of study Primary · To evaluate the effect of Virechana Karma and Patra Pinda Sweda Followed byViswadi Dwadashanga Kwatha in the management of Mamsagata Vata with special reference to Fibromyalgia Secondary To compare the effect of Virechana Karma and Patra Pinda Sweda Followed by Viswadi Dwadashanga Kwatha in the management of Mamsagata Vata with special reference to Fibromyalgia
|