| CTRI Number |
CTRI/2023/08/057030 [Registered on: 29/08/2023] Trial Registered Prospectively |
| Last Modified On: |
27/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate effectiveness of karanjadi lepa in dadru with special referance to bahihparimarjan chikista siddhant (when locally applied) |
|
Scientific Title of Study
|
A single arm clinical study to evaluate efficacy of karanjadi lepa in dadru with special referance to bahihparimarjan chikista 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 |
Vd Sneha Chitali |
| Designation |
PG Scholar |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalay, Hadapsar |
| Address |
OPD no 2 Kaychikitsa OPD Ground Floor Sane Guruji Arogya Kendra hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
7264024711 |
| Fax |
|
| Email |
snehakchitali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nilesh Kulkarni |
| Designation |
Professor |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalay, Hadapsar |
| Address |
3rd Floor Department of Samhita Sane Guruji Arogya Kendra, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
8805335512 |
| Fax |
|
| Email |
prof.dr.nileshkulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nilesh Kulkarni |
| Designation |
Professor |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalay, Hadapsar |
| Address |
3rd Floor Department of Samhita Sane Guruji Arogya Kendra, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
8805335512 |
| Fax |
|
| Email |
prof.dr.nileshkulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ayu Samhita & siddhant and Department of Kayachikitsa Sane Guruji Arogya kendra Malwadi Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vd Sneha Chitali |
Sane Guruji Arogya Kendra |
Department of Ayu samhita and siddhant and Department of kayachikitsa sane guruji arogya kendra malwadi hadapsar pune
Pune
MAHARASHTRA |
7264024711
snehakchitali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAM’s Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra, Hadapsar InstitutionalEthicalComitee |
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, (2) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karanjadi lepa, Reference: Charak Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 50(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient will be diagnosed on the basis of signs and symptoms of dadru kushta as per mentioned in classical text
All types of tinea will be included
Less chronic than 3 years |
|
| ExclusionCriteria |
| Details |
Patient suffering from major systemic disorder and immunocompramise disorder
Patient having patches due to burn, chemical exposure |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreaaed signs and symptoms of disease such as itching,redness,number of patches,size of patches after treatment |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the efficacy of Karanjadi Lepa in Dadru even after the stoppage of the treatment |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
04/09/2023 |
| 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
|
This is a single arm clinical study to evaluate the efficacy of karanjadi lepa in dadru with special referance to bahihparimarjan chikista siddhant.The primary objective is to study efficacy of karanjadi lepa in dadru when given for 15 days .60 patients will participtae in respective study with symptoms related to skin disease dadru as per mentioned in text with karanjadi lepa by exetrnal application.Again patients will be observed after 15 days without giving any treatment to check permanant result of drug. Observatiions will be noted from outcome of treatment. |