| CTRI Number |
CTRI/2025/02/080732 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Eladi tail in management of Kotha |
|
Scientific Title of Study
|
Study the effect of Eladi Taila application in the management of Kotha caused by Viruddha Ahara |
| 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 Shradha Bhagwan Pawar |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| Address |
Bharati Vidyapeeth Deemed to be University College of Ayurved
Department of Agad tantra OPD No:- 26
Dhankawadi Campus Katraj Pune
Pune
MAHARASHTRA
411043
India
Bharati Vidyapeeth Deemed to be University College of Ayurved
Department of Agad tantra OPD No:- 26
Dhankawadi Campus Katraj Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
7057576827 |
| Fax |
|
| Email |
shradha.pawar-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Prasad Namewar |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| Address |
Bharati Vidyapeeth Deemed to be University College of Ayurved
Department of Agad tantra OPD No:- 26
Dhankawadi Campus Katraj Pune
Pune
MAHARASHTRA
411043
India
Bharati Vidyapeeth Deemed to be University College of Ayurved
Department of Agad tantra OPD No:- 26
Dhankawadi Campus Katraj Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
8830260392 |
| Fax |
|
| Email |
prasad.namewar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suryajeet Pawar |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| Address |
BhaBharati Vidyapeeth Deemed to be University College of Ayurved
Department of Agad tantra OPD No:- 26
Dhankawadi Campus Katraj Pune
Pune
MAHARASHTRA
411043
India
Bharati Vidyapeeth Deemed to be University College of Ayurved
Department of Agad tantra OPD No:- 26
Dhankawadi Campus Katraj Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
9762865005 |
| Fax |
|
| Email |
suryajeet.pawar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Department of Agadtantra ,
Bharati Vidyapeeth Deemed to be University
College of Ayurved & Hospital, Pune 411043 , Maharashtra , India |
|
|
Primary Sponsor
|
| Name |
Dr Shradha Pawar |
| Address |
Bharati Vidyapeeth Deemed to be University College of Ayurved
OPD No:- 26 Department of Agad tantra
Dhankawadi Campus Katraj Pune
Pune
MAHARASHTRA
411043
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 Shradha Pawar |
Bharati Vidyapeeth Deemed to be University |
OPD No :-26 department of Agad tantra Bharati Ayurved Hospital pune
Pune
MAHARASHTRA |
7057576827
shradha.pawar-ayurved@bvp.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE [BV(DU)COA-EC] |
Approved |
| ETHICS COMMITTEE [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L508||Other urticaria. Ayurveda Condition: KOTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Cetrizine | Medicine Name: Tab.Cetrizine 5mg
Route: oral
Dosage Form: tablet
Dose: 5mg
Frequency: SOS
Duration: SOS | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eladi Taila , Reference: Ashtang Hruday Sutra Sthan, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Local Application on affected site(2) Medicine Name: Avipatthi Yoga , Reference: Ashtang Hrudaya Kalpa Sthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: Medicine taken on 0th , 7th, 15th, 21st, 30th |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All diagnosed cases of Kotha .
Kotha will be diagnosed with the symptoms - Bahumandala( Multiple Wheals), Kandu (Itching), Raga (Erythema) with their gradations specified in subjective parameters.
All the patients of either sex or age group of 18 to 60 years.
Patients showing Kotha due to Viruddha Ahara . |
|
| ExclusionCriteria |
| Details |
Patients those are suffering from uncontrolled diabetes mellitus, high blood pressure,and history of tuberculosis, HIV, hepatitis B, known cases of malignancy (CA).
known case of any allergy exposure causing urticaria
Patients accompanied with other skin diseases.
Patients showing Kotha due to Hetu other than Viruddha Ahara |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the gradation of signs of Kotha might be seen in trial group compared to standard control group. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the value of eosinophils might be seen in trial group compared to standard control group. |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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
Modification(s)
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Not Any |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized controlled , parallel group study on efficacy of eladi taila in Kotha for 30 days in 24 patients with kotha that will be conducted in Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Department of Agad Tantra, Katraj, Dhankawadi, Pune - 411043. The primary outcome measures reduction in the gradation of signs of Kotha might be seen in trial group compared to standard control group. |