| CTRI Number |
CTRI/2023/07/055004 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
07/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of chitrakadi oil and patoladi gana formulation in ring worm infestation of skin |
|
Scientific Title of Study
|
Effect of external application of chitrakadi taila along with internal administration of patoladi gana kasaya 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 |
Dr Sreethu Krishna R J |
| Designation |
MD scholar |
| Affiliation |
Government Ayurveda College Panchakarma Hospital Thiruvananthapuram |
| Address |
Department of Agadatantra
Government Ayurveda College
Panchakarma Hospital
Poojappura
Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9746257040 |
| Fax |
|
| Email |
sreethukrishna2014@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
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
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9895196434 |
| Fax |
|
| Email |
ayuprasanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurveda college Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda college Thiruvananthapuram |
| Address |
Sreethu Krishna R J
Department of Agadatantra
Government Ayurveda College Thiruvananthapuram |
| Type of Sponsor |
Other [Government Ayurveda College, Thiruvananthapuram ] |
|
|
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 Sreethu Krishna R J |
Government Ayurveda College Panchakarma Hospital |
Government Ayurveda College Panchakarma Hospital
Op no 3 Department of Agadatantra
Poojappura 695012
Thiruvananthapuram
KERALA |
9746257040
sreethukrishna2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical 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: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi taila, Reference: Yogaratnakara , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Patoladi gana kashaya, Reference: Ashtanga hridayam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of both sexes in age group 18- 60 years having signs and symptoms- itching, peripheral papules /vesicle /scales, spreading nature of tinea corporis.
2.Participants with positive KOH test
|
|
| ExclusionCriteria |
| Details |
1.Children, pregnant women and lactating mothers.
2.Participants with any other skin diseases which need further medication.
3.Participants with uncontrolled systemic illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the assessment parameters – itching, papules, vesicles, scaling, spreading nature, |
0th day
31st day
46th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| KOH test |
Oth & 46 th day |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
15/07/2023 |
| 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
|
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 ring worm of specialized sites such as the scalp, feet, and groins. It may be transmitted by direct contact with other infected individuals or by infected animals. It is not a life-threatening condition but it affects the daily activities of human being. The signs and symptoms of tinea corporis can be correlated with dadru based on its pattern of spreading, morphology of lesion, itching and chronicity. Dadru is classified under KshudraKushta by Charka Samhita and under MahaKushta by SusruthaSamhitha and AshtangaHridaya. The fungus grows best in warm moist environment. Thus, recurrence of dermatophytosis is very common. Hence proper research is needed for the effective management of this disease. The study drug Chitrakadi taila is mentioned in kushta chikitsa chapter of yogaratnakara. Chitrakadi taila consist of chitraka, karaveera and vidanga by its tikshna and krimighna property can give quicker effect. The primary objective of this study is to evaluate the effect of Chitrakadi taila and Patoladigana Kashaya in tinea corporis. It will be a pre and post interventional study with a sample size of 26 within the age group of 20-60 years. The participants satisfying inclusion criteria will be selected from OPD of Department of Agadathantra, Govt. ayurveda college Thiruvananthapuram. The trial drug Chitrakadi taila and coarse powder of Padoladi gana Kashaya will be given for a period of 30 days. Data will be collected before and after treatment, scored and statistically analysed using appropriate statistical technique. |