| CTRI Number |
CTRI/2025/07/090731 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate The Efficacy Of Trimurti Agada And Vishghna Lepa In
The Management Of Dushivishajanya Dadru With Special Reference To Recurrent
Tinea |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of internally Trimurti Agada And externally Vishghna Lepa In
The Management Of Dushivishajanya Dadru With Special Reference To Recurrent
Tinea A Single Arm Open Labelled Clinical Trial |
| 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 Ganesh venktarajam Mamidala |
| Designation |
MD (Agadtantra) scholar |
| Affiliation |
Sumatibhai Shah Ayurved mahavidyalaya hadpsar Pune |
| Address |
O.P.D. NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune
O.P.D No.4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
7208106334 |
| Fax |
|
| Email |
ganeshmamidala30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manohar khankhane |
| Designation |
Head of department Agadtantra |
| Affiliation |
Sumatibhai Shah Ayurved mahavidyalaya hadpsar |
| Address |
O.P.D. NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune
O.P.D No.4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
918888763651 |
| Fax |
|
| Email |
khankhanemanohar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh venktarajam Mamidala |
| Designation |
MD Agadtantra scholar |
| Affiliation |
Sumatibhai Shah Ayurved mahavidyalaya |
| Address |
O.P.D. NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune
O.P.D No.4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune
Pune
Pune
MAHARASHTRA
411029
India |
| Phone |
7208106334 |
| Fax |
|
| Email |
ganeshmamidala30@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMS Sumatibhai Shah Ayurved College O.P.D NO 4 Agadtantra Department Ground Floor
Sane guruji Arogya Kendra Hadapsar Pune-411028 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr. Ganesh venktarajam Mamidala |
| Address |
O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune-411028 Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
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 Ganesh venktarajam Mamidala |
Sane guruji arogya kendra Hadpsar pune |
O.P.D NO 4 Agadtantra
Department ground floor
Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
72081 06334
ganeshmamidala30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MAMS Sumatibhai Shah Ayurved Mahavidyalaya And Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L530||Toxic erythema. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: trimurti agada, Reference: vishavaidya sarsamuchhay uttarbhag sarvavishahar prayoga adhyay shlok 40 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: charak sutrasthana , Procedure details: application of vishaghna lepa over affected area in required quantity twice a day for 60 days in pratiloma gati)
(1) Medicine Name: vishghna lepa, Reference: charak sutrasthana 3/28, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: bd, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
This trial will include all the patients of Dadru having classical signs and
symptoms like, Kandu (Itching), Raga (Erythema), Pidaka (Papillae),
Mandalamudgatama (Discoid lesion with elevated border) along with sign
and symptoms of Dushivisha like., Dhatukshaya, Vaivarnya, Avipaka,
Arochaka irrespective of gender, religion, profession, socioeconomic
stat
Dadru which are Recurrent in nature (minimum 2 times in a year).
Patient willing to accept the participation in the clinical trial. |
|
| ExclusionCriteria |
| Details |
Patient suffering from severe, or complicated systemic disease like,
Chronic kidney disease, Liver disease and VDRL disease will be excluded
from the trial study.
Dadru which are newly originated (Recurrent rate Less than 2 times in
year).
Patients who are not willing for inclusion in the study.
Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The patient will be withdrawn from the study if patient complains of any adverse
reaction, not responding to the treatment or any serious complication occur due
to treatment will be referred to the higher center.
Between the trial period; if any serious complication develops requiring urgent
treatment such as pyoderma, prolonged fever due to infected skin lesions, patients
will be referred appropriately. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Trimurti agada and vishgna lepa in recurrent tinea in
every 15 days Till 60days |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Symptomatic relief drugs are available having action as anti-histaminic, antifungal, topical application and systemic steroids having known side effects. Hence people suffering from Tinea infections are turning towards safe and effective remedies in Ayurveda. In Ayurveda, there are two types of Chikitsa i.e., Antahparimarjana (internal administration) and Bahirparimarjana (external administration). In Twaka vikara internal administration of Churna is recommended along with external application of Lepa as well[3] One such formulation as Trimurthi Agada is first of all mentioned by Acharya Charaka in visha chikitsa adhyaya, indicated in Twaka vikara in the context of Sarva visha avastha. The same reference is also mentioned in Sushruta Samhita [4]and Ashtanga Sangraha, but with different ingredients. For the present research work, reference of Charaka Samhita will be taken. Trimurthi Agada is a formulation indicated in Sarvavishahar yoga and it’s action is less explored. It is mentioned in Prayoga Samuchhaya[5] , panchama parichheda , Sarvavisha chikitsa adhyaya and Vishavaidyasarasamucchayam[6], uttarbhaga, sarvavishahara chapter,40thsloka.Trimurthi Agada is one of the formulations mentioned in both text books as sarvavishahara yoga. The yoga is purely herbal combination of only three drugs namely Nimba, Nili and Karanja. Bhavana is done with its own patra swarasa. [5] Vishghna Lepa which is mentioned by Acharya Charaka in Sutrasthana 3rd Adhyay useful in different skin diseases. |