| CTRI Number |
CTRI/2025/10/096520 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study effect of
Vishwamitra Kapala Malahara
locally in Vicharchika. |
|
Scientific Title of Study
|
Clinical study to evaluate efficacy of Vishwamitra Kapala Malahara locally in 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 Japa Jayant Phadke |
| Designation |
PhD Scholar |
| Affiliation |
Seth Govindaji Raoji Ayurved Mahavidyalaya,Solapur |
| Address |
3rd Floor, Department of Kayachikitsa,Seth Govindaji Raoji Ayurved Mahavidyalaya, Near Samrat Chowk,Solapur
Solapur
MAHARASHTRA
413001
India |
| Phone |
8600248131 |
| Fax |
|
| Email |
phadkejapa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vivek Chandurkar |
| Designation |
HOD and Professor Kayachikitsa |
| Affiliation |
Seth Govindaji Raoji Ayurved Mahavidyalaya,Solapur |
| Address |
3rd Floor, Department of Kayachikitsa,Seth Govindaji Raoji Ayurved Mahavidyalaya, Near Samrat Chowk,Solapur
Solapur
MAHARASHTRA
413001
India |
| Phone |
9422788569 |
| Fax |
|
| Email |
vivek.chandurkar@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Japa Jayant Phadke |
| Designation |
PhD Scholar |
| Affiliation |
Seth Govindaji Raoji Ayurved Mahavidyalaya,Solapur |
| Address |
3rd Floor, Department of Kayachikitsa,Seth Govindaji Raoji Ayurved Mahavidyalaya, Near Samrat Chowk,Solapur
Solapur
MAHARASHTRA
413001
India |
| Phone |
8600248131 |
| Fax |
|
| Email |
phadkejapa@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research Centre and PDEAs Ayurved Rugnalaya and Snowbell Multispeciality Hospital , Sector No 27 , Nigdi ,Pune, Maharashtra , India 411044 |
| Seth Govindaji Ayurved Mahavidyalaya and Seth Sakharam Nemchand Jain Ayurved Hospital, Solapur, Maharashtra, India 413001 |
|
|
Primary Sponsor
|
| Name |
Dr Japa Phadke |
| Address |
Floor no.3, Department of Kayachikitsa, Seth Govindaji Raoji Ayurved Mahavidyalaya,Near Samrat chowk,Solapur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Japa Phadke |
PDEAs Ayurved Rugnalaya and Snowbell Multispeciality Hospital |
Kayachikitsa, OPD No.117,Ground Floor,PDEAs Ayurved Rugnalaya and Snowbell Multispeciality Hospital, Sector no.27, Nigdi ,Pune 411044
Pune
MAHARASHTRA |
8600248131
phadkejapa@gmail.com |
| Dr Japa Phadke |
Sakharam Nemchand Jain Ayurved Hospital |
Kayachikitsa OPD No.1,Ground floor, Sakharam Nemchand Jain Ayurved Hospital, Shukravar Peth, Solapur 413002
Solapur
MAHARASHTRA |
8600248131
phadkejapa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee College of Ayurveda and Research Centre Nigdi Pune |
Approved |
| Institutional Ethical Committee Seth Govindagi Raoji Ayurved Mahavidyalaya Solapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L308||Other specified dermatitis. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vishwamitra Kapala Malahara, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, 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 |
1. Age group:- 18 to 60 years.
2.Patients with Clinical features of Vicharchika having signs and symptoms namely Kandu
(itching),Pidaka(Eruption),Vaivarnya(Depigmentation) and Srava (Discharge).
3.Patients of both Gender.
4.Understanding and being willing to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
1. Patient having severe systemic diseases or condition along with Vicharchika.
2. Pregnant & Lactating woman. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the Vishwamitra Kapala Malahara twice daily locally for the period of 30 days in age
group of 18 to 60 years with irrespective of gender in Vicharchika using EASI SCALE.
|
30 Days.
Patient will be screened on 15th and 30th days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To Study any adverse reaction of drug to the patient.
2.To study the disease Vicharchika in detail with Ayurveda |
30 Days.
Patient will be screened on 15th and 30th days. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
25/11/2025 |
| 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="3"
Months="0"
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
|
The present study is planned to evaluate the efficacy of Vishwamitra Kapala Malahara in the management of Vicharchika, a chronic relapsing skin disorder described in Ayurveda as a type of Kshudra Kushta and correlated with eczema in modern medicine. Vicharchika is characterized by itching, eruptions, discoloration and discharge, causing considerable physical, cosmetic and psychological burden. Modern treatment with corticosteroids and emollients offers only temporary relief with chances of recurrence, while Ayurveda provides holistic alternatives. According to Ayurvedic principles, Vicharchika is Tridoshaja with Kapha predominance and involvement of Rasa, Rakta, Mamsa and Kleda. Vishwamitra Kapala Malahara, a traditional formulation from Vaidya parampara, though not mentioned in classical texts, has been reported to show beneficial effects in skin diseases but has not been scientifically evaluated in Maharashtra. This study will be a single arm controlled clinical trial conducted at the OPD and IPD of Kayachikitsa departments at Solapur and Pune. A total of 108 patients of either gender, aged 18 to 60 years, fulfilling the diagnostic criteria of Vicharchika will be enrolled. The intervention will consist of local application of Vishwamitra Kapala Malahara twice daily for 30 days, with follow-up on day 0, 15 and 30. Assessment will be done using subjective criteria such as Kandu, Pidaka, Vaivarnya and Srava, along with objective scoring through the Eczema Area and Severity Index (EASI). Data will be analyzed using appropriate statistical methods to evaluate significance of outcomes. The formulation will be prepared from coconut shells using Bhallataka Patan Yantra for oil extraction and mixed with Tuttha to form Malahara. The expected outcome is reduction in clinical symptoms, improved quality of life, minimal adverse effects and establishment of a safe, cost-effective Ayurvedic intervention for Vicharchika, thereby providing scientific validation to this traditional Anubhuta Yog. |