| CTRI Number |
CTRI/2024/11/077315 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF SWARNAGADI YOG IN FUNGAL INFECTION |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE EFFECT OF SWARNANGADI
YOGA IN DADRU WITH SPECIAL REFERENCE TO TINEA CARPORIS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GAGAN |
| Designation |
P G SCHOLAR |
| Affiliation |
R.A.PODAR (AYU)MEDICAL COLLEGE,ANEE BISANT ROAD ,WORLI ,18 |
| Address |
DEPARTMENT OF KAYACHIKITSHA OPD NO. 18/19, M.A. PODAR HOSPITAL,ANEE BISANT ROAD,WORLI MUMBAI
Mumbai
MAHARASHTRA
400018
India |
| Phone |
6375327901 |
| Fax |
|
| Email |
gaganpipar11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUKUND MAGARE |
| Designation |
ASSOCIATE PROFESSOR,DEPARTMENT OF KAYACHIKITSHA |
| Affiliation |
R.A.PODAR AYU MEDICAL COLLEGE,ANEE BISANT ROAD,WORLI MUMBAI,18 |
| Address |
DEPARTMENT OF KAYACHIKITSHA OPD NO. 18/19, M.A. PODAR HOSPITAL,ANEE BISANT ROAD,WORLI MUMBAI
Mumbai
MAHARASHTRA
400018
India |
| Phone |
6375327901 |
| Fax |
|
| Email |
mukundmagare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GAGAN |
| Designation |
P G SCHOLAR |
| Affiliation |
R.A.PODAR AYU MEDICAL COLLEGE,ANEE BISANT ROAD,WORLI MUMBAI,18 |
| Address |
DEPARTMENT OF KAYACHIKITSHA,OPD NO. 18/19 ,M.A. PODAR HOSPITAL,ANEE BISANT ROAD,WORLI MUMBAI
Mumbai
MAHARASHTRA
400018
India |
| Phone |
6375327901 |
| Fax |
|
| Email |
gaganpipar11@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 18/19,KAYACHIKITSHA DEPARTMENT,M A PODAR AYURVED HOSPITAL,WORLI,MUMBAI,PIN CODE 400018 |
|
|
Primary Sponsor
|
| Name |
R.A.PODAR MEDICAL COLLEGE (AYU),WORLI,MUMBAI 18 |
| Address |
R.A.PODAR MEDICAL COLLEGE (AYU),ANEE BISANT ROAD WORLI,MUMBAI
PIN CODE 400018 |
| Type of Sponsor |
Government medical college |
|
|
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 GAGAN |
MAHADEVI ANANDILAL PODAR GOVT HOSPITAL, ANEE BISANT ROAD, WORLI MUMBAI |
DEPARTMENT OF KAYACHIKITSHA OPD NO.18/19 ,M.A. PODAR HOSPITAL,ANEE BISANT ROAD,WORLI MUMBAI
Mumbai
MAHARASHTRA |
06375327901
gaganpipar11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS committe of institution,R.A. podar medical (ayu0 college,worlir |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: SWARNANGADI YOG , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -kosanjal ), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: BHANDIRADI YOG, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -kosanjal ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient with sign and symptoms of Dadru like Kandu, Pidika, Vaivarnya
and mandala.
2) Understanding and Being willing to sign the informed concent form . |
|
| ExclusionCriteria |
| Details |
1. Patient having skin lesion other than Dadru kushtha (Tinea corporis) like Eczema,
psoriasis, urticaria etc.
2. Pregnancy and lactating mother.
3. Immuno-compromised patients like AIDS (HIV positive), HbsAg positive etc.
4. Person With Severe Disorder Like CA,liver disorder, renal or cardiac problems, bed
ridden due to chronic illness.
5. patient having uncontrolled DM/HTN.
6. Any complication arising during the treatment of any patient discontinuing
treatment will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of swarnangadi yog on rag(redness),kandu(itchhing),pidika
2.To study the effect of swarnagadi yog on area of dadru |
4 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To review the ayurvedic & modern literature on dadru
2.To asses the possible mode of action of swarnangadi yog |
at 1st, 2nd, 3rd and 4th total 28 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/12/2024 |
| 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)
|
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
|
Tawcha is out covering of body. skin play in important immunity role in protecting the body against pathogenes and excessive water loss In ayurveda the word kushtha is broad term which covers almost all skin disorders acharya charak described 18 type of kushtha then classified in sub type 7 mahakustha and 11 khudra kustha .dadru is among in these kshudra kustha while according to susruta it is mahakustha. dadru is tridoshj twak vikara with pitta-kapha predominance.it invole clinical features like kandu,raga,pidika,mandala
Scope of study : to evaluate the effect of swarnangadi yog in the treatment of dadru
Expected outcomes: ? changes in symptoms of dadru like rag ,kandu,pidika. ? Effect of swarnangadi yog could be more then the effect of bhandiradi yog |