| CTRI Number |
CTRI/2024/10/075480 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Triphaladi kashay in ringworm |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of triphaladi kwath and triphaladi udvartana in the management of dadru(tinea corporis) according to apatarpana siddhant. |
| 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 More Gauri Daulatrao |
| Designation |
PG scholar |
| Affiliation |
Ashtang ayurved mahavidyalay pune |
| Address |
Samskritam samhita siddhant department room no.1 Ashtang ayurved mahavidyalay
2062 sadashiv peth late vd H B paranjape chowk pune pin 411030
Pune
MAHARASHTRA
411030
India |
| Phone |
7744064333 |
| Fax |
|
| Email |
gaurimore5353@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manojkumar Chaudhari |
| Designation |
Associate professor ( sanskrit samhita siddhant) |
| Affiliation |
Ashtang ayurved mahavidyalay pune |
| Address |
Samkritam samhita siddhant department room no 1 Ashtang ayurved mahavidyalay 2062 sadashiv peth late vd H B paranjape chowk pune pin 411030
Pune
MAHARASHTRA
411030
India |
| Phone |
9552509052 |
| Fax |
|
| Email |
manojsamhita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manojkumar Chaudhari |
| Designation |
Associate professor ( sanskrit samhita siddhant) |
| Affiliation |
Ashtang ayurved mahavidyalay pune |
| Address |
Samkritam samhita siddhant department room no 1 Ashtang ayurved mahavidyalay 2062 sadashiv peth late vd H B paranjape chowk pune pin 411030
Pune
MAHARASHTRA
411030
India |
| Phone |
9552509052 |
| Fax |
|
| Email |
manojsamhita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Samskritam samhita siddhant department Ashtang ayurved mahavidyalay 2062 sadashiv peth late Vd H B paranjape chowk pune India pin 411030 |
|
|
Primary Sponsor
|
| Name |
Dr More Gauri Daulatrao |
| Address |
Samskritam samhita siddhant department Ashtang ayurved mahavidyalay 2062 sadashiv peth late vd H B paranjape chowk pune India pin 411030 |
| 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 More Gauri |
Ashtang ayurved hospital |
Kaychikitsa opd room no 3 Ashtang ayurved hospital 2062 sadashiv peth late vd H B paranjape chowk pune
Pune
MAHARASHTRA |
7744064333
gaurimore5353@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphaladi kwath, Reference: Charak samhita sutrasthan 23, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: Ashtang hruday sutrasthan 2, Procedure details: Patient of this group are treated with triphaladi churn in udvartanam form that is the act of rubbing the powder with some friction on the body at the site of dadru 2 to 3 times a day.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with any of classical signs and symptoms of dadru kushtha like itching, redness, elevation of skin, ring formation |
|
| ExclusionCriteria |
| Details |
Patient with other skin disorders like Eczema Psoriasis.Patient suffering from diabetes mellitus.Patient suffering from auto immune disorders like SLE |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| triphaladi churna in both kwath and udvartana form are effective in the management of Dadru as per Apatarpana siddhant |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any one of triphaladi kwath and triphaladi udvartana is more effective than other in the management of dadru |
After 30 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/10/2024 |
| 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 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
|
After diagnosed patient will be treated as per procedure follow uo will be taken. statistical analysis will be done and after getting result and discussion on result summary of the thesis will given. |