| CTRI Number |
CTRI/2025/12/098343 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Tail And Lepa] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFICACY OF MAHABHALLATAKA TAIL AND EDAGAJADI LEPA IN THE MANEGEMENT OF VICHARCHIKA. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON EFFICACY OF MAHABHALLATK TAIL AND EDAGAJADI LEPA IN THE MANGEMENT OF DUSHIVISHJANYA VICHARCHIKA |
| 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 Mandavi Gupta |
| Designation |
PG Scholar |
| Affiliation |
OPD No 09 Dept of Agad Tantra Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
OPD No 09 Dept of Agad Tantra Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8878880626 |
| Fax |
|
| Email |
mandavi.gupta1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prafulla |
| Designation |
Proffesor And HOD of Agadtantra Department |
| Affiliation |
OPD No 09 Dept of Agad Tantra Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
OPD No 09 Dept of Agad Tantra Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9826602746 |
| Fax |
|
| Email |
prafullas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandavi Gupta |
| Designation |
PG Scholar |
| Affiliation |
OPD No 09 Dept of Agad Tantra Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
OPD No 09 Dept of Agad Tantra Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8878880626 |
| Fax |
|
| Email |
mandavi.gupta1991@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mandavi Gupta |
| Address |
OPD No 09 Dept of Agad Tantra Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| 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 Mandavi Gupta |
Rani Dullaiya Smriti Ayurved And Hospital Bhopal |
OPD No 9 Department of Agadtantra Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH |
8878880626
mandavi.gupta1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Rani Dullaiya Smriti Ayurveda PG College and Hospital Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mahabhallataka Tail, Reference: R.R.Samuchaya, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mahabhallataka Tail, Reference: R.R.Samuchaya, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Edgajadi lepa, Reference: Chakradutta , Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as the case of Dushivishjanya Vicharchika with the presenting
symptoms
Patients willing to participate in the clinical trial. |
|
| ExclusionCriteria |
| Details |
Age less than 18 years & more than 70 years.
Patients suffering from major illness & infections disease like scabies, Dermatophytosis
etc.
Patient suffering from Dushivishjanya Vicharchika associated with other systemic illness
like diabetes mellitus & other complications |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessed for efficacy in the management of Vicharchika |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced in symptoms of itching, discharge, discolouration and complete relief of vicharchika |
30 Days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/12/2025 |
| 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="5"
Days="0" |
|
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
|
The skin lesion with itching boil (eruption), darkness and profuse oozing. Vicharchika is a Kaphaja dosha pradhana vyadhi, in contemporary science it can be correlated with Eczema. Eczema or dermatitis is an inflammatory response of the skin to multiple agents, characterized by erythema, edema, vesiculation, oozing, crusting and later lichenification. Various Visha and Upavisha are used in medicinal formulation because of their quick action. That’s why in this present research work Mahabhallatak Tail And Edagajadi Lepa are the two formulations taken for the study over Dushivishjanya Vicharchika. |