| CTRI Number |
CTRI/2024/05/067731 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Kusthahar kashay ghan and Manjisthadi tail in fungal infection. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of kusthahar kashay ghan and Manjisthadi tail in Dadru kustha with special referance to Fungal Dermatophytosis. |
| 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 Sameer Pralhad Shinde |
| Designation |
Ph D Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli,Kolhapur. |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre,Kaychikitsa Department, Kodoli,Taluka Panhala, District Kolhapur.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7507043414 |
| Fax |
|
| Email |
sameershubha85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryakiran Wagh |
| Designation |
Professor and HOD |
| Affiliation |
Yashwant Ayurvedic college post graduate Training and Research centre, Kodoli, Kolhapur |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre,Kayachikitsa Department,Kodoli, Taluka Panhala, District Kolhapur.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822846910 |
| Fax |
|
| Email |
suryakiran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Shinde |
| Designation |
Ph D Scholar |
| Affiliation |
Yashwant Ayurvedic college Poast Graduate Training and Research Kodoli, Kolhapur. |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre , Kayachikitsa Department Kodoli, Taluka Panhala District Kolhapur.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7507043414 |
| Fax |
|
| Email |
sameershubha85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara. |
| Yashwant Ayurvedic College Post Graduate Training and Research centre Kodoli Kolhapur. |
|
|
Primary Sponsor
|
| Name |
Dr Sameer Pralhad Shinde |
| Address |
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Department of kayachikitsa, Satara. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sameer Shinde |
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara |
Room No 3,OPD Block,Department of Kayachikitsa M.N.Aghashe Aryangla Hospital Satara.
Satara
MAHARASHTRA |
7507043414
sameershubha85@gmail.com |
| Dr Suryakiran Wagh |
Yashwant Ayurvedic college Post Graduate Training and Research centre Kodoli, Kolhapur |
Room No 17, Ground Floor,Institutional Building,Kayachikitsa Department,Kodoli,Kolhapur.
Kolhapur
MAHARASHTRA |
9822846910
suryakiran_wagh@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutational Ethics Committee Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kolhaour |
Approved |
| Institutional Ethics Committee Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection 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 (Non Ayurveda) | | - | Drug | Clotrimazole 1% ointment for local application on affected site twice daily for 28 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushthahar kashay ghan, Reference: Sahastrayogam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishthadi tail, Reference: vrindmadhav kushtha chikitsa, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm (Non Ayurveda) | | - | Drug | Tab Fluconazole 150 mg orally once a week after meal for 28 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical signs and symptoms of Dadru kustha like Udgat mandal(Raised skin patch), Kandu(Itching),Raga (redness),Pidaka(eruption), Daha(Burning). |
|
| ExclusionCriteria |
| Details |
preganant and lactating Mothers
Patients having chrnicity of Dadru Kustha more than 5 yrs
Patients having serious illness like HIV, Maliganancy,Cardiac Disease, Major Liver Diseases,End Stage Renal Disease.
Patients having other associated skin diseases liks Eczema, SLE and Secondary Bacterial infections. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the antifungal activity of Kushthahar kashay Ghan and Manjishthadi Tail in Dadru Kushtha. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse reactions if any After administration of Kusthahar kashay ghan and Manjisthadi Tail |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
30/05/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sameershubha85@gmail.com].
- For how long will this data be available start date provided 01-06-2024 and end date provided 01-01-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This Clinical study is aimed to evaluate efficacy of Kusthahar kashay ghan and Manjisthadi tail in Dadru Kustha. This is Randomized Controlled Clinical Trial. Total 130 patients of Dadru Kustha will be devided in 2 groups of 65 each. Trial group will receive Kusthahar kashay ghan 500mg Orally bd and Manjisthadi Tail for local application for 28 days and Controll group will get Tab Fluconazole 150 mg once a week orally and Clotrimazole 1% ointment forLocal application for 28 days. Hypothesis Null Hypothesis :H0: Kusthahar kashay ghan (500mg)orally ang Manjisthadi tail (Local Application) for 28 days is not significantly effective in dadru kustha with special referance to fungal dermatophytosis.
Alternate Hypothesis: H1:Kushtahar Kashay Ghan (500mg) orally and Manjisthadi Tail (local application) for 28 days is significantly effective in Dadru kustha with special referance to fungal dermatophytosis. |