| CTRI Number |
CTRI/2025/07/090720 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Treatment ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised comparative study of chakramarda siddha taila and karanja taila in topical management of dadru with special reference to tinea cruris. |
|
Scientific Title of Study
|
A randomised comparative study of Chakramarda Siddha Taila and
Karanja Taila in topical management of Dadru with special reference
to Tinea Cruris. |
| 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 Dnyaneshwar Arjun Khairnar |
| Designation |
Post Graduate Scholar |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill |
| Address |
Left wing room no.3, Ashvin Rural Ayurved College and Hospital, Sadvi preetisudhaji maharaj nagar, Manchi Hill Ashvi bk, Tal- Sangamner, Dist- Ahamadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
7448018030 |
| Fax |
|
| Email |
kdnyanesh20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Jaywant Jadhav |
| Designation |
Reader |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill |
| Address |
Left wing room no.3, Ashvin Rural Ayurved College and Hospital, Sadvi preetisudhaji maharaj nagar, Manchi Hill Ashvi bk, Tal- Sangamner, Dist- Ahamadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9822676928 |
| Fax |
|
| Email |
avish1091@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dnyaneshwar Arjun Khairnar |
| Designation |
Post Graduate Scholar |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill |
| Address |
Left wing room no.3, Ashvin Rural Ayurved College and Hospital, Sadvi preetisudhaji maharaj nagar, Manchi Hill Ashvi bk, Tal- Sangamner, Dist- Ahamadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
7448018030 |
| Fax |
|
| Email |
kdnyanesh20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Dnyaneshwar Arjun Khairnar |
| Address |
Left wing room no.3, Ashvin Rural Ayurved College and Hospital, Sadvi preetisudhaji maharaj nagar, Manchi Hill Ashvi bk, Tal- Sangamner, Dist- Ahamadnagar |
| 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 Dnyaneshwar Arjun Khairnar |
Ashvin Rural Ayurved College and Hospital |
Kayachikitsa Department OPD and IPD, Left wing room no.3, Ashvin Rural Ayurved College and Hospital, Sadvi preetisudhaji maharaj nagar, Manchi Hill Ashvi bk, Tal- Sangamner, Dist- Ahamadnagar
Ahmadnagar
MAHARASHTRA |
7448018030
kdnyanesh20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashvin Rural Ayurved College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases 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 | Classical | | (1) Medicine Name: Chakramarda siddha Taila , Reference: Bhavaprakash, Atha Haritkyadi varga, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Dose as per affected area | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karanja Taila , Reference: Charak Chikitsa, adhyay 7, Shloka 119, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Dose as per affected area |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with classical signs and symptoms of Dadru(Tineacruris) less than 1 years.
Patient of both genders irrespective of caste, Religion.
Patients having Tinea over Inguinal, Thigh regions only. |
|
| ExclusionCriteria |
| Details |
Patient on steroid treatment
Tinea with other skin disease
HIV infected patient
Any Systemic disease
Tinea infection other than Tinea cruris |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Chakramarda siddha taila in topical management
of Dadru. |
Total duration of medicine will be 30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
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 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/07/2025 |
| 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
|
A skin disease Dadru has a social importance, The numbers of patients are increasing day by day. Patients taking modern local applications and steroids but after stopping treatment disease get worsened. In Ayurvedic statistics various medicines are prescribed for Dadru Roga Chikitsa, so our goal is to find out effective herbal formulation which will have less side-effects and will cause low economic burden. In recent years there has been increase in incidence of skin problem due to various reasons like Poverty, Poor sanitation, Unhygienic condition Pollution etc. Dadru is one among Kshudraroga affecting all the age of population. It is Kapha Pitta Pradhan Vyadhi and presents clinically with the features of Kandu, Pidaka, Daha, Rookshata, Mandala etc and can be correlated with Tinea infection Management of Dadru includes Shodhana, Shaman and Bahiparimarjan Chikitsa. Chakramarda has Dadrughna property as per Dhanwantari and Bhavaprakash Nighantus and in Charak Chakramarda and Karanja taila has Kushthghna property. So here in this study of Chakramarda Taila and Karanja Taila comes under Bahiparimarjan chikitsa was used to evaluate the efficacy in Dadru. |