| CTRI Number |
CTRI/2025/06/088287 [Registered on: 05/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Mole removal with the help of shankadrava liquid. |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Shankhadrava application for removal of Mashaka to avoid its recurrence w.s.r. to mole. |
| 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 Hrishikesh Vishnu Kolhe |
| Designation |
MS Scholar Shalyatantra Samanya Department |
| Affiliation |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar, Hiravadi, Panchavati, Nashik,
Maharashtra 422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
7775810624 |
| Fax |
|
| Email |
hrishkolhe2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Raut |
| Designation |
H.O.D. Shalyatantra Department |
| Affiliation |
Department of Shalyatantra Samanya,Shree Saptashrungi Ayurved Mahavidyalaya,Nashik |
| Address |
Department of Shalyatantra Samanya,Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822979769 |
| Fax |
|
| Email |
dr.aparnaraut12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hrishikesh Vishnu Kolhe |
| Designation |
M.S. Scholar Shalyatantra Samanya Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 420003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
7775810624 |
| Fax |
|
| Email |
hrishkolhe2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatanta department,OPD no. 1,Shree Saptashrungi Ayurved Mahavidyalaya And Hospital ,
KamalNagar , Hirawadi , Panchwati, Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003 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 |
| Dr Hrishikesh Vishnu Kolhe |
Department Of Shalyatanta,Shree Saptashrungi Ayurved Mahavidyalaya And Hospital |
Department Of
Shalyatanta,OPD no.
1,Shree Saptashrungi
Ayurved Mahavidyalaya
And Hospital, Kamal
Nagar , Hirawadi ,
Panchawati , Nashik
422003
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
7775810624
hrishkolhe2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya Nashik Panchavati Nashik Maharashtra 422003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L918||Other hypertrophic disorders of the skin. Ayurveda Condition: MASHAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shankhadrava , Reference: Rasatarangini Dwadashtarang 35-39, Route: Topical, Dosage Form: Arka, Dose: 0.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: Topical application of shakharava arka 2 times a day over mole site only |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
a)Individuals of mashaka(mole) having hard, painless, black and Elevated eruption on the body (skin) resembling the masha (pulse) in shape.
b)Sites:-face (except eyelids),legs, back,chest,neck,groin region
c)Patients in the age group of 18 to 40 years.
d)Patients will be selected irrespective of sex, religion, socio – economic status etc. |
|
| ExclusionCriteria |
| Details |
1)The patient age group is less than 18 and more than 40 years.(Baal,vruddha,Durbal,pregnant women also) 2)Tilkalaka of shuk roga. 3)Patient suffering from any other skin disorders like psoriasis, dermatitis, vitiligo, melasma, malignant melanoma and acne.
4) Patient having chronic infectious diseases like Koch’s, leprosy, Hypersensitivity, cancer and diabetes. 5)Contraindicated to Shankhadrava application
Raktapitta (bleeding disorders) ,Timira (eye disease), Moorchha (unconscious), Sira (head), Snayu (tendons), Sandhi (joints), Tarunasthi (ligament bones), Dhamani. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of shankhadrava drops application in mashaka removal from its base and to check its recurrence. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse effect of Shankhadrava application.
mole characteristics from modern perspective. |
30 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 2 |
|
Date of First Enrollment (India)
|
16/06/2025 |
| 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="0"
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
|
This is a Phase I/II single-arm clinical trial aimed at evaluating the efficacy and safety of Shankhadrava, an Ayurvedic preparation, in the management of Mashaka (moles). The study will assess the potential of Shankhadrava to remove moles from their base and prevent recurrence through its cauterizing and detoxifying properties. A total of 40 eligible participants, aged 18–40 years, presenting with Mashaka will receive topical application of Shankhadrava for a maximum of 21 days. The trial will monitor changes in mole characteristics (size, color, elevation, texture), recurrence, and any adverse effects. The findings may provide a natural, cost-effective alternative to modern mole removal techniques. |