| CTRI Number |
CTRI/2020/07/026503 [Registered on: 10/07/2020] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on round ring patches of skin its causes and treatment. |
|
Scientific Title of Study
|
Nidanatmaka study of Dadru Kushtha and Upashayatmaka Randomised trial to
evaluate the efficacy of Mulakadi Lepa and Guduchyadi kwatha in the
management of Dadru Kushtha. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Prakash Verma |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Roga Evam Vikriti Vigyana National Institute
of Ayurveda Madhav Vilas Palace Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7976582140 |
| Fax |
|
| Email |
rv29690@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B K Sevatkar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Roga Evam Vikriti Vigyana National Institute
of Ayurveda Madhav Vilas Palace Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9352311105 |
| Fax |
|
| Email |
drbks6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Prakash Verma |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Roga Evam Vikriti Vigyana National Institute
of Ayurveda Madhav Vilas Palace Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7976582140 |
| Fax |
|
| Email |
rv29690@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Madhav Vilas Palace Amer Road Jaipur
Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace Amer Road Jaipur 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ravi Prakash Verma |
Arogyashala NIA |
OPD No. 17 PG Department of
Roga Evam Vikriti Vigyana
National Institute of
Ayurveda Madhav Vilas
Palace Amer Road Jaipur
Jaipur
RAJASTHAN |
7976582140
rv29690@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchyadi
Kwatha |
GROUP B: 50 Patients this group will receive
Guduchyadi Kwatha for internal use. Dose:
Guduchyadi kwatha (24 ml prepared from 12 gms
dry raw medicine) BD before meal. |
| Intervention |
Mulakadi
Lepa |
GROUP A: 50 Patients this group will receive
Mulakadi Lepa for local application. Dose: Mulakadi
Lepa use for local application 10 to 20 grams
(according to size and area of affected lesion) once
in a day. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Patient with the classical sign and symptoms of Dadru Kushtha
viz. kandu, raga, pidika and mandala.
b. Patients 18 years to 60 years of age will be included.
c. Patients belonging to either gender will be included. |
|
| ExclusionCriteria |
| Details |
a. The patient suffering from severity systemic disorders will be
excluded.
b. The pregnant women and lactating mother will be excluded.
c. Patient less than 18 yrs and above 60 yrs of age will be excluded.
d. Skin malignancy and other skin diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in skin lesions (mandala). |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the following signs and symptoms- kandu,raga, pidika |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/07/2020 |
| Date of Study Completion (India) |
12/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dadru involves the clinical features like Kandu, Deerghapratana, Utsanna, Mandala, Raaga, Pidakas, which exhibits involvementof Kapha and Pitta. Acharya Vagbhata especially mentioned Dadru as Anusangika.Ayurvedic classics have considered each type of Kushtha to be a Tridoshaja manifestation. Nonetheless, their Doshik identity can established based on dominance of Dosha in the Samprapti. Thus, Dadru is purely Kaphaja phenomenon. Based on presenting symptomatology most of the scholars have similated Dadru with ’Fungal dermatocytes through modern perspective. It comes under, superficial fungal infections of the skin. Globally, up to 20% of the population may be infected by ringworm at any given time AIMS AND OBJECTIVE: To conduct a Nidanatmaka (survey) study to know the etiopathogenesis of ‘Dadru’ Kushtha. To evaluate and compare the efficacy of Guduchyadi Kwatha & Mulakadi Lepa in the management of ‘Dadru’ Kushtha. HYPOTHESIS: NULL HYPOTHESIS (H0): Trial drugs Mulakadi Lepa and Guduchyadi kwatha are no difference in the management of ‘Dadru’ Kushtha ALTERNATIVE HYPOTHESIS (H1): Trial drugs Mulakadi Lepa and Guduchyadi kwatha are difference in the management of ‘Dadru’ Kushtha |