| CTRI Number |
CTRI/2025/08/092287 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to evaluate the efficacy of Ayurvedic intervention in Dadru Kushta with special reference to Dermatophytosis. |
|
Scientific Title of Study
|
Randomised controlled clinical trial to evaluate the efficacy of Ayurvedic Intervention in DADRU KUSHTHA with special reference to Dermatophytosis. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savnika |
| Designation |
BAMS |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Jorawar Singh gate AMER road Jaipur RAJASTHAN 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7987376490 |
| Fax |
|
| Email |
Svanika18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savnika |
| Designation |
BAMS |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Jorawar Singh gate AMER road Jaipur RAJASTHAN 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7987376490 |
| Fax |
|
| Email |
Svanika18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin Shamrao Sawant |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 |
| Address |
National Institute of Ayurveda Jorawar Singh gate AMER road Jaipur RAJASTHAN 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9890275426 |
| Fax |
|
| Email |
drsawantps@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Deemed to be university (DE-NOVO), Jorawar Singh Gate, Amer Road, Jaipur 302002, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Deemed to be university DENOVO Jaipur |
| Address |
National Institute of Ayurveda , amer road , jorawar singh gate , jaipur 302002, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Savnika |
National Institute of Ayurveda, Deemed to be University (De-novo), Jaipur |
OPD No. 1 Kayachikitsa department, National Institute of Ayurveda , amer road , jorawar singh gate , jaipur
Jaipur
RAJASTHAN |
7987376490
svanika18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda, Deemed to be University (De-novo), Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, (2) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Paribhadra Rasa, Reference: Basavrajeeyam Kustharoganidanalakshanachikitsa adhyaya (13/118-119), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: (2) Medicine Name: , Reference: Dadruvidravana Malhara, Route: RasaTarangini (4 / 59-62), Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 41(10), Frequency: g, Bhaishajya Kal: bd, Duration: Pragbhakta, anupAna/sahapAna: No, Additional Information: -(3) Medicine Name: , Reference: Nishotha and Kutaki Churna, Route: Charak chikitsasthan, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 9(3), Frequency: g, Bhaishajya Kal: hs, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: -Luke warm water | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet Flucanazole and Ketoconazole 2%. Ointment | tablet Fluconazole 150mg , once a week orally and Ketoconazole 2% Ointment Local application as per the size of lesion, twice a
day . |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to participate in clinical trial and provide informed consent.
2.The patients fullfilling the diagnostic criteria of Dadru Kushtha lakshanas such as-
A. Kandu (itching)
B. Raga(erythma)
C. Pidika(eruptions)
D. Utasanna mandala(elevated circular lesions)
3.Patients with chronocity of illness less than five years. |
|
| ExclusionCriteria |
| Details |
1.Patients with long-term history of steroid and cytotoxic treatment.
2.History of hypersensitivity or allergy to study drugs.
3.Patients having concomitant illness like uncontrolled Hypertension, Diabetes Mellitus and known
case of HIV, Malignancy.
4.Patients having other associated skin disease like eczema, secondary bacterial infection, etc.
5.Patient participated in any clinical trial with in last six months.
6.Presence of any other serious medical condition that may interfere with study participation.
7.Severe renal Impairment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study will be relief in kandu (itching) at the end of the treatment period. |
Baseline to the end of the treatment period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes will include changes in subjective & objective parameters such as
kandu(itching), Raga(erythema), Pidika (eruptions) & Utasanna mandala (elevated circular skin lesion).
- Changes in QOL using the DLQI [Dermatology Life Quality Index . |
Baseline, 21st day & 42th day(end of the treatment period). |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="0"
Months="1"
Days="12" |
|
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
|
TITLE RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF
AYURVEDIC INTERVENTION IN DADRU KUSHTHA WITH SPECIAL REFERENCE TO
DERMATOPHYTOSIS.
Background All the skin diseases in Ayurveda have been classified under the broad heading of Kushtha. There are eighteen types of kushtha roga which classified in to Mahakustha and ksudra kustha, Charaka
explained Dadru under Kshudra Kushtha. Sushruta and Ashtanga Hridaya explained it under
Mahakushta. Dadru is a tridoshaja vyadhi with predominant vitiation of Pitta and kapha dosha having
clinical features like kandu(itching),Raga(erythema),Pidika (eruptions) and Utasanna mandala (elevated
cicular skin lesion)according to charaka. As per Sushruta, it is Kapha Dosha involvement. It can be closely
related to Dermatophytosis in contemporary science.
Null Hypothesis [Ho]:
There is no difference in the efficacy between ayurvedic intervention and standard
contemporary intervention in Dadru kushtha with special reference to Dermatophytosis.
Alternative Hypothesis [HA]:
There is difference in the efficacy between ayurvedic intervention and contemporary standard
intervention in Dadru kushtha with special reference to Dermatophytosis.
Number of Groups:
There will be two groups: Ayurvedic Intervention group and Conventional standard group.
Sample Size:
Sample size required is 60 patients.
Duration of treatment:
The duration of treatment will be 42 days.
GROUPING
Group A:- Intervention: Nishotha and Kutaki Churna , Paribhadra Rasa and Dadruvidravana Malhara
Group B:- Intervention: Flucanazole and Ketoconazole 2%.
OUTCOME AND SIGNIFICANCE The study aims to provide scientific evidence on Ayurvedic treatments as an alternative to conventional therapies, reducing dependency on ANTI FUNGAL and steroids while improving patients’ quality of life. |