| CTRI Number |
CTRI/2025/01/078914 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Compare the effectiveness of haridragandhaka choorna and nimbaharidradi choorna and internal administration of patoladigana formulation in ring worm infestation of skin. |
|
Scientific Title of Study
|
A comparative clinical trial on the effectiveness of external application of haridragandhaka choorna with keratailam versus nimbaharidradi choorna with takra along with internal administration of patoladigana kashaya in tinea corporis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRASEELAP |
| Designation |
MD Scholar |
| Affiliation |
Government Ayurveda College Panchakarma Hospital Thiruvananthapuram |
| Address |
Department of Agadatantra
Government Ayurveda College
Panchakarma Hospital
Poojappura
Thiruvananthapuram
KERALA
695012
INDIA
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9539985515 |
| Fax |
|
| Email |
praseelap922@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanth S R |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Panchakarma Hospital Thiruvananthapuram |
| Address |
Department of Agadatantra
Government Ayurveda College
Panchakarma Hospital
Poojappura
Thiruvananthapuram
KERALA
695012
INDIA
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9895196434 |
| Fax |
|
| Email |
ayuprasanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanth S R |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Panchakarma Hospital Thiruvananthapuram |
| Address |
Department of Agadatantra
Government Ayurveda College
Panchakarma Hospital
Poojappura
Thiruvananthapuram
KERALA
695012
INDIA
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9895196434 |
| Fax |
|
| Email |
ayuprasanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College
Panchakarma hospital
Poojappura
Thiruvananthapuram
Kerala
695012
India |
|
|
Primary Sponsor
|
| Name |
Praseela P |
| Address |
Department Of Agadatantra
Government Ayurveda College
Panchakarma hospital
Poojappura
Thiruvananthapuram
Kerala
695012
India |
| Type of Sponsor |
Other [Government Ayurveda College Panchakarma hospital Poojappura Thiruvananthapuram Kerala 695012 India] |
|
|
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 Praseela P |
Government Ayurveda College Panchakarma Hospita Thiruvananthapuraml |
Government Ayurveda College Panchakarma Hospital
OP No 3
Department of Agadatantra
Poojappura
695012
Thiruvananthapuram
Kerala
India
Thiruvananthapuram
KERALA |
9539985515
praseelap922@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Government Ayurveda College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridragandhaka choorna, Reference: Keetadivishaprakarana of Kriyakaumudi, Route: Topical, Dosage Form: Churna/ Powder, Dose: 50(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -Applied with keratailam | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nimbaharidradi choorna , Reference: Ashtangahridaya chikitsasthana, Route: Topical, Dosage Form: Churna/ Powder, Dose: 50(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Applied with takra |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants in age group 18-60 years irrespective of gender presenting with at least any two of symptoms - itching, peripheral papules, vesicles, scales, spreading nature of Tinea corporis assessed by modified total symptom score for dermatophytosis
2.Participants with positive KOH test |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating mothers
2.Participants with any other skin diseases which need further medication
3.Participants with uncontrolled systemic illness
4.Participants with known case of sulpha allergy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the assessement parameters - itching, papules, vesicles , scaling , spreading nature |
0th day
31st day
46th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| KOH test |
0th & 46th day |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 3 |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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 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
|
Tinea corporis is a widely seen dermatological manifestation encountered in daily clinical practices. Tinea corporis is ring worm of the glabrous skin. By definition it includes lesion of the trunk and limbs , excluding the ring worm of specialized sites such as scalp, feet, and groins. It can be correlated with dadru under kshudrakushta by charaka samhita and mahakushta by susruta samhita and ashtangahridaya. The study drug Haridragandhaka choorna is mentioned in Keetadivishaprakarana of Kriyakaumudi. Haridragandhaka choorna consists of haridra and gandhaka by its ushna veerya and krimighna properties . The study drug Haridragandhaka choorna with keratailam will be given for one group and Nimbaharidradi choorna with takra will be given for 2nd group and coarse powder of Patoladigana kashaya will be given for both groups for a period of 30 days. |