| CTRI Number |
CTRI/2025/01/079622 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Ayurvedic Medicine On Scabies |
|
Scientific Title of Study
|
SINGLE BLIND CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF BAHIRPARIMARJAN (EXTERNAL APPLICATION) OF CHOPCHINAYADI TAIL ON PAMA KUSHTHA WITH SPECIAL REFERENCE TO SCABIES. |
| 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.Sandeep Gorakh Mane |
| Designation |
Professor Kayachikitsa Department |
| Affiliation |
Siddhakala Ayurved College Sangamner |
| Address |
Kayachikitsa Department 3 rd Flour OPD No.1 Siddhakala Ayurved College Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9420014073 |
| Fax |
02424220925 |
| Email |
drsgmane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ganesh Tukaram Aher |
| Designation |
Professor HOD PAnchkarma Department |
| Affiliation |
Siddhakala Ayurved College Sangamner |
| Address |
HOD Panchkarma Department 3rd Flour Room No.2
Siddhakala Ayurved College Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
989847761 |
| Fax |
02425220925 |
| Email |
drganeshaher77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Ganesh Tukaram Aher |
| Designation |
Peofessor HOD Panchkarma Department |
| Affiliation |
Siddhakala Ayurved College Sangamner |
| Address |
HOD PAnchkarma Department 3 rd Flour Room N0.2 Siddhakala Ayurved College Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9890847761 |
| Fax |
02425220925 |
| Email |
drganeshaher77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sandeep Mane Department Of Kayachikitsa Siddhakala Ayurved College 3rd Flour Room No.1 Sangamner Ahilyanahar maharashtra India 422605 |
|
|
Primary Sponsor
|
| Name |
Maharashtra University Of Health Sciencies |
| Address |
Maharashtra University Of Health Sciencies ,Dindori Road,Mhasural, Nashik 422004 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| DrSandeep Gorakh Mane |
Siddhakala Hospital |
Department Of Kayachiktsa 3rd Flour Romm no.1 Siddhakala Ayurved College Sangamner
Ahmadnagar
MAHARASHTRA |
9420014073
02425220925
drsgmane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituational Ethical Comitee Siddhakal Ayurved College Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B86||Scabies. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: chopchinayadi tail, Reference: classical text, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Permethrin lotion | permetharin lotion 10 ml BID for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients Present With Symptoms Of Pama Kustha
Absence Of Discharge |
|
| ExclusionCriteria |
| Details |
Kustha Other Than Pama/Scabies
Patients Suffering From Any Other Systemic Disorder
Pama Associated With Immunodeficiency Disorder
Scabies With Complication Of Crust
Presence Of Discharge
Patient Unwiiling For Clinical Trial
Patient Not Willing For Written Consent And Plan Of Treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Efficacy Of Chopchinaydi Tail on Pama Kustha in reducing Pitika(Papules)size and number |
1.On zero day base line assessment and follow up on 7 th ,14 th and 21 st day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Pama Kustha With Reference To Scabies
To Study Scabies From Modern Point Of View
to study chopchinaydi tail effect on pama kushtha with permetharin lotion in 2nd group asessment on 1st week,2nd week ,and 3rd week |
Two years |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/02/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Pama Kustha is Ayurvedic Term For Scabies Pama Is Treated With External Application Of Chopchinyadi Tail And Permetherin Lotion All Information Collected After The Final Assessment Of Stastical Analysis Total 80 Patients Will Be Collected For Trial Subjective Criteria Observed Before And After Study
|