| CTRI Number |
CTRI/2020/02/023153 [Registered on: 06/02/2020] Trial Registered Prospectively |
| Last Modified On: |
21/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare khadirasara taila and chakramarda taila in the treatment of fungal skin disease. |
|
Scientific Title of Study
|
Comparative open label randomized clinical study to evaluate the effect of Khadira Sara Taila with Chakramarda Taila in the management of Dadru(Tinea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SREELAKSHMI S |
| Designation |
MD SCHOLAR |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
SAI SIVER OAK,KALEWADI ,PUNE MAHARASHTRA,411017.
Sant tukaram nagar,pimpricolony,pimpri-chinchwad pune,Maharashtra 411018
Pune
MAHARASHTRA
411019
India |
| Phone |
8848927129 |
| Fax |
912027122125 |
| Email |
drsreelakshmisobhanadhan93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jibi Varghese |
| Designation |
Associate professor kayachikitsa department |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Center |
| Address |
Ayur Arogyam,plot 507/25,nigdi,pune 411044
Nigdi Pradhikaran
Sant tukaram nagar,pimpricolony,pimpri-chinchwad pune,Maharashtra 411018
Pune
MAHARASHTRA
411044
India |
| Phone |
8983478062 |
| Fax |
912027122125 |
| Email |
vjayu82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jibi Varghese |
| Designation |
Associate professor kayachikitsa department |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Center |
| Address |
Nigdi,pune 411044
Nigdi Pradhikaran
Sant tukaram nagar,pimpricolony,pimpri-chinchwad pune,Maharashtra 411018
Pune
MAHARASHTRA
411044
India |
| Phone |
8983478062 |
| Fax |
912027122125 |
| Email |
vjayu82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y patil college of ayurved and research center |
|
|
Primary Sponsor
|
| Name |
Dr D Y patil college of ayurved and research center |
| Address |
sant tukaram nagar Pimpri pune18 |
| Type of Sponsor |
Private medical college |
|
|
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 Sreelakshmi S |
Dr D Y patil college of ayurved and research center |
Kayachikitsa OPD and IPD.
Dr D Y Patil college of ayurved and research center.
sant tukaram nagar pimpri pune 18
Pune
MAHARASHTRA |
8848927129
drsreelakshmisobhanadhan93@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patient should be in a good healthy condition.They should not have any hypertensive,diabetes or thyroid history. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chakramarda taila |
to be applied locally as per requirement daily morning and evening.
The duration of the study will be 15 days.(0-7th day-15 th day) |
| Intervention |
khadira sara taila |
to be applied locally as per requirement daily morning and evening
Duration of the study will be 15 days(0-7th day-15 th day) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients with signs and symptoms of dadrukushta |
|
| ExclusionCriteria |
| Details |
1)Chronic illness and infection like TB,DM,Skin cancer,psoriasis,generalized eczema
2)Malignant condition and HIV infection
3)Person who is taking modern medicine for ringworm infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to get cured of the ringworm infection |
The cure shall be assessed in 2 follow ups in fifteen days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| getting cured of the marked symptoms on skin adding to the cosmetic effect. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| Date of Study Completion (India) |
27/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/03/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The aim of the study was to find the effectiveness of chakramarda taila and khadirasara taila in the management of Dadru. The study has been conducted with two groups .First group was given with khadirasara taila and second group with chakramarda taila for a duration of 15 days( a follow up in between after each 7 th day).Total 60 patients were enrolled for the study.in the study,Most patients were presented with the symptoms kandu (itching) and raga (burning sensation).A very few patients had comme up with other symptoms of Dadru like rukshatha(dryness),pidika(eruptions),mandala(circular patches). Both the drugs seem to be equally effective in the disease Dadru. |