| CTRI Number |
CTRI/2024/09/073705 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on the combined efficacy of gomutra haritaki tablet and nalpamaradi oil in Dermatophytosis |
|
Scientific Title of Study
|
Open label single arm clinical study on the combined efficacy of gomutra haritaki vati and nalpamaradi taila in dadru (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 Raj Maheshbahi Patel |
| Designation |
pg scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan |
| Address |
Department of Kayachikitsa
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road, Thanniruhalla
Hassan-573201
KARNATAKA
India
Hassan
KARNATAKA
573201
India |
| Phone |
8141763930 |
| Fax |
|
| Email |
rajp17070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Totad Muttappa |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road, Thanniruhalla
Hassan-573201
KARNATAKA
India
Hassan
KARNATAKA
573201
India |
| Phone |
9886924949 |
| Fax |
|
| Email |
drtotadmuttappa@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
DR Totad Muttappa |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road, Thanniruhalla
Hassan-573201
KARNATAKA
India
Hassan
KARNATAKA
573201
India |
| Phone |
9886924949 |
| Fax |
|
| Email |
drtotadmuttappa@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, BM Road, Thanniruhalla,
Hassan-573201
Karnataka,
India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, BM Road, Thanniruhalla,
Hassan-573201
Karnataka,
India |
| 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 |
| DrRaj Maheshbahi patel |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan |
Department of kayachikitsa opd number 7 Sri Dharmasthala
Manjunatheswara
College Of Ayurveda
And Hospital BM
Road,Thanniruhalla,
Hassan-573201
Karnataka, India
Hassan
KARNATAKA
Hassan
KARNATAKA |
8141763930
rajp17070@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases 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: Gomutra haritaki vati , Reference: Sodhala Kayachikitsa Khanda Kushtachikitsa verse150 In Pandeya GS editor Vidyotini Commentary by Indradev tripathi Gadnigraha 1st edition Delhi Chaukhamba Sanskrit Sansthan 2011 Vol II p 788., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants suffering with Dadru up to 1 year of duration.
2.Participants of either gender.
3.Participants aged between 18-60 years.
4.Participants willing to participate in the study and ready to sign informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Participants with Tinea mannus, Tinea pedis, Tinea unguium (Onychomycosis).
2.Participants with known case of uncontrolled Diabetes Mellitus (HbA1C greater than 8).
3.Participants with known case of Sexually Transmitted Diseases.
4.Patient taking any immune suppression drugs.
5.Pregnant women.
6.Lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment will be based on the symptoms
Kandu (Itching) , Raga (Erythema).
2.Pidaka (Eruption) , Mandala (Annular patches) , Centrifugal lesion , Well-demarcated border |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pidaka.
2.Size of Mandala.
3.No. of Mandala.
|
14 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
26/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/07/2025 |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The symptoms
of Dadru are closely resembles with symptoms of Dermatophytosis (Tinea). Dermatophytes
are the most frequent causative agents of superficial fungal infections, which affects
keratinized tissue3. As India being a tropical country, there has been a rise in chronic and
relapsing dermatophytosis which shown the prevalence of 65.3% and 34.6% respectively4. The
infection rates were highest among the age groups involved in occupational and outdoor
activities due to the increased exposure to fungal pathogens from the environment and
increased perspiration, both predispose to fungal infection5.
The present state of dermatophytosis has emerged as a social, psychological and economic
burden on the society. Dadru is a Kapha-Pitta pradhana vyadhi with Kandu, Raga, Pidaka and Mandala. So
necessitating the use of medicines have Tikta, Kashaya rasa & property such as Dadrughna,
Kandughna or Kushtaghna. Gomutra Haritaki vati has Dadrughna property & Nalpamaradi
taila has Kandughna and Kushtaghna property |