| CTRI Number |
CTRI/2025/09/094289 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Interventional Clinical Trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of Ayurvedic pastes made from Karanj seeds and Mango seed with Haritaki in reducing dandruff. |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Karanj Beej Lepa Verses Aamrabeejmajja Haritaki Lepa in the Management of Darunaka (Pityriasis Capitis) – A Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIl |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHUBHANGEE ARJUN PATHADE |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital Research Centre Salod Wardha |
| Address |
Room no 30 Department of Samhita Siddhant Mahatma Gandhi Ayurved College and Research Centre Salod Wardha Maharashtra
Department of Samhita Siddhant Panini Lab Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7498953431 |
| Fax |
|
| Email |
shubhangeepathade23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Borkar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra |
| Address |
Room no 21 Department of Samhita Siddhant Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra
Department of Samhita Siddhant Panini Lab Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8446127058 |
| Fax |
|
| Email |
preeti.borkar@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Borkar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra |
| Address |
Room no 21 Department of Samhita Siddhant Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra
Department of Samhita Siddhant Panini Lab Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8446127058 |
| Fax |
|
| Email |
preeti.borkar@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001 Maharashtra |
|
|
Primary Sponsor
|
| Name |
SHUBHANGEE ARJUN PATHADE |
| Address |
Department of Samhita Siddhant Mahatma Gandhi Ayurved College and Research Centre Salod Wardha 442001 Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SHUBHANGEE ARJUN PATHADE |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha State Maharashtra |
Room no 30 Department of Kayachikitsa Wardha MAHARASHTRA
Wardha
MAHARASHTRA |
7498953431
shubhangeepathade23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Ayurved College Hospital and Research Centre Wardha State Maharashtra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L210||Seborrhea capitis. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aamrabeejmajja Haritaki Lepa, Reference: SharangdharSamhita , Yog Ratnakar, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karanj Beej Lepa, Reference: Aadarsh Nighantu, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Fulfilling the diagnostic criteria which are based on clinical signs and symptoms of Darunaka
Patients willing for treatment with informed consent |
|
| ExclusionCriteria |
| Details |
Patients not willing for the enrollment in the clinical trial known cases of severe scalp and skin disorder systemic illness HIV AIDS pregnancy or lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Releving the signs and symptoms of Darunaka Pityriasis Capitis with as simple and easy intervention Karanj Beej Lepa |
Within three weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Founding Releving the Darunaka Pityriasis Capitis with as simple and easy intervention Karanj Beej Lepa |
One year |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
01/01/2026 |
| 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="6"
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 volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H), Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They will be divided into two groups as the trial is a parrallel group, randomised, open clinical, standard controlled trial. It will incluid a 3 weeks treatment period and follow up. |