| CTRI Number |
CTRI/2025/07/090230 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use Of Munditikadi Churna In Vatarakta |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial Of Munditikadi Churna Along With Guduchi Kwath In Vatarakta |
| 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 Vishwjeet Vijaykumar Powar |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
OPD No. 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9373014344 |
| Fax |
|
| Email |
vishwjeetpowar55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parag Narayan Deshmukhe |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
3rd Floor Department Of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
7719954457 |
| Fax |
|
| Email |
pdeshmukhe@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parag Narayan Deshmukhe |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
3rd Floor Department Of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
7719954457 |
| Fax |
|
| Email |
pdeshmukhe@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Vishwjeet Vijaykumar Powar |
| Address |
OPD No 1 Kayachikitsa OPD Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli 416301 |
| 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 Vishwjeet Vijaykumar Powar |
Hon Shri Annasaheb Dange Ayurved Medical COllege Post Graduate And Research Center Ashta |
Department of Kayachikitsa OPD/IPD
Sangli
MAHARASHTRA |
9373014344
vishwjeetpowar55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Munditikadi Churna, Reference: Dhanvantari Nighanatu, Guduchyadi varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Guduchi Kwath), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gud Haritak, Reference: Dhanwantari Nighantu, Guduchyadi Varga , Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Guduchi Kwath), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients would be selected Irrespective of their
Gender.
2.Patient presenting with lakshanas of vatrakta like
Toda,shoth,daha and
Sthabdhata.(10) |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactating woman.
2. Patient having major systemic illness. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Munditikadi churna along with guduchi kwath in the management
Vatarakta. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gud Haritaki along with guduchi kwath in the management
Vatarakta. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
15/07/2025 |
| 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) |
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
|
Vatarakta is a disease related with khavaigunya found in raktavaha strotas which include vitiated vata and rakta, so termed as vatarakta. Due to properties sukshmatva and saratva of vayu, dravatva and saratva of rakta they spread all over body. Vatarakta is a disease of Raktavaha strotas and is a Madhyam margagata vyadhi. (1) Prakupit Vayu along with Raktadushti travels in whole body & affects the joint starting with Parvasandhi especially Padangushta. Vatarakta is described as an independent disease as Vat-Shonita in CharakSamhita, Vagbhat and other samhitas The etiology and symptoms of gout is very much similar to those of vatarakta. Gout is a condition characterized by pathological reaction of joints or particular tissues. Purine is an important byproduct of incomplete protein metabolism, leading into the excess of production of uric acid through their metabolic pathways.The prevalence of Vatrakta is 2.5%.Gout is a chronic inflammatory condition caused by the deposition of MonosodiumUrate (MSU) crystal.It is caused by factors that elevate the concentration of SUA (Serum Uric Acid), leading to hyperuricemia. Continued elevated SUA can result in MSU (Monosodium Urate) crystal deposition in all over body, including joints, soft tissues, cartilage, and organs. The peak age of onset in males is between 40 and 60 years. Hyperurecemia can be defined as the serum uric acid level more than 7 mg/dL in males and 6 mg/dL in females.Classically, gout has been described as occurring in four stages: 1.asymptomatic hyperuricemia, 2.acute gouty arthritis,3. intecritical gout, and 4.advanced or chronic gout |