| CTRI Number |
CTRI/2024/08/073128 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Vrishadi lepa for the treatment of tinea/dermatomycosis |
|
Scientific Title of Study
|
A clinical trial to evaluate the effect of vrishadi lepa in the management of dadru kustha w.s.r to dermatomycosis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMoumita Tewari |
| Designation |
Pg scholar |
| Affiliation |
SDM College of Ayurveda and Hospital, Kuthpady, Udupi |
| Address |
Department of agadatantra vyavahara ayurveda evum vidhi vaidyaka
SDM Ayurveda Medical College & Hospital
Udupi
Karnataka
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
7001359096 |
| Fax |
-- |
| Email |
moumitatewary2110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShrinidhi R Ballal |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Ayurveda and Hospital Kuthpady, Udupi |
| Address |
Department of pg studies in agadatantra vyavahara ayurveda evum vidhi vaidyaka
SDM Ayurveda Medical College Kuthpady
Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8867205846 |
| Fax |
--- |
| Email |
drshrinidhi3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShrinidhi R Ballal |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Ayurveda and Hospital Kuthpady, Udupi |
| Address |
Department of pg studies in agadatantra vyavahara ayurveda evum vidhi vaidyaka
SDM Ayurveda Medical College Kuthpady
Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8867205846 |
| Fax |
--- |
| Email |
drshrinidhi3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri dharmasthala manjunatheswara college of ayurveda Kuthpady,Udupi
Pin Code-574118
Karnataka,India |
|
|
Primary Sponsor
|
| Name |
DrMoumita Tewari |
| Address |
SDM College of Ayurveda Kuthpady Udupi
Pin no-574118
Karnataka,India |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 |
| DrMoumita Tewari |
Shri dharmasthala manjunatheswara collyof ayurveda and hospital |
Department of agadatantra vyavahara ayurveda evum vidhi vaidyaka OPD-6 skin Kuthpady Udupi
Udupi
KARNATAKA |
07001359096
--
moumitatewary2110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HUMAN INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Lepa | (Procedure Reference: Sushruta Samhita, Procedure details: Vrishadi lepa will be advised to apply with the Sukhoshna Jala, once a day in the morning with the thickness of lepa as Ardhardha Bhagah (approx. 4-5 mm) & will be asked to wash out once it starts drying.
All the patients fitting inclusion criteria and who can give consent, will be given Vrishadi Lepa for external application once a day for 7 days. Results will be analysed before treatment, 7th and 14th day of the course of treatment.
)
(1) Medicine Name: VRISHADI LEPA, Reference: Harita Samhita , Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with history of sign and symptoms of Dadru Kustha fulfilling the diagnostic criteria
2.Patient of either sex within the age of 18 to 70 years are selected for the study
|
|
| ExclusionCriteria |
| Details |
Children, pregnant women, lactating mothers and patients with comorbidities like thyrotoxicosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in signs and symptoms of dadru
Changes in KOH examination test
Improvement of Subjective parameters like itching, redness,burning sensation and dryness of skin |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is an open labelled randomized controlled clinical study to evaluate the effect of vrishadi lepa in the management of dadru kustha w.s.r to dermatomycosis,wherein minimum 30 patients diagnosed with dadru kustha,will be selected irrespective of their gender,caste and crees.The signs and symptoms will be scored on the basis of standard method and will be analysed statistically. Vrishadi lepa quantity sufficient for application once a will be given .Total duration of study will be 14 days,study will be conducted at Shri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Kuthpady, Udupi Karnataka India.The primary outcome measures will be assessed base on changes in the signs and symptoms of dadru,changes in the Koh examination, improvement on the basis of subjective and objective parameters.Hence an effort has been planned through this clinical study evaluate the effect of vrishadi lepa in dadru kustha. |