| CTRI Number |
CTRI/2025/02/080763 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF PREEYAL BEEJADI SHAMPOO IN DANDRUFF |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF PRIYAL BEEJADI SHAMPOO OVER PRIYAL BEEJADI LEPA IN THE MANAGEMENT OF DARUNAKA W.S.R. TO DANDRUFF |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRVIKRAMSINH NAVANATH BALWANTRAO |
| Designation |
PG Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma
Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal
Bagalkot
KARNATAKA
587315
India |
| Phone |
8381002021 |
| Fax |
|
| Email |
balwantraovikramsinh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadev S Badiger |
| Designation |
Professor and HOD |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma
Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal
Bagalkot
KARNATAKA
587315
India |
| Phone |
9036701207 |
| Fax |
|
| Email |
drmsb123@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahadev S Badiger |
| Designation |
Professor and HOD |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma
Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal
Bagalkot
KARNATAKA
587315
India |
| Phone |
9036701207 |
| Fax |
|
| Email |
drmsb123@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic
Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Bagalkot Karnataka |
|
|
Primary Sponsor
|
| Name |
DR VIKRAMSINH NAVANATH BALWANTRAO |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduation
Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant
Nagar Terdal 587315 Bagalkot Karnataka |
| 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 VIKRAMSINH NAVANATH BALWANTRAO |
Padma Ayurvedic Hospital And Research Centre |
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma
Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal
Bagalkot
KARNATAKA |
08381002021
balwantraovikramsinh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTs Ayurvedic Medical College And Padma Ayurvedic Hospital INSTOTUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L219||Seborrheic dermatitis, unspecified. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Head Bath | (Procedure Reference: , Procedure details: • Take sufficient quantity of Lepa & mix with small amount of water,
which makes it easy for application.
• The Lepa should be applied (thickness of lepa similar to doshagna lepa i.e
¼ angula) gently by using tip of three fingers all over the scalp & allowed
to situ for 45mins.
• Then gently wash it with normal water )
| | 2 | Intervention Arm | Procedure | - | Head Bath | (Procedure Reference: , Procedure details: • Wet hair & scalp thoroughly with water
• Apply sufficient quantity of shampoo to produce enough lather to wash the
scalp & hair
• Gently massage it over the entire scalp & leave for 3-5 min
• Rinse scalp thoroughly with water )
|
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient with classical signs and symptoms of Darunaka and Dandruff.
2 Patient of Age group between 15 to 50yrs with irrespective of gender.
3 Patient willing to sign and give consent. |
|
| ExclusionCriteria |
| Details |
1 Patient with secondary scalp infections.
2 Patient diagnosed with any other disease related to the scalp scalp psoriasis
tinea capitis seborrheic dermatitis contact dermatitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Trial Drug on Improvement in the symptoms of Darunaka(Dandruff) |
7day,14day,21day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Saftey of trial drug and Adverse Drug Reaction Aggravation of symptoms of Darunaka (Dandruff) |
7day,14day,21day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="1"
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
|
Danuraka, a scalp disorder in Ayurveda, is comparable to dandruff. It’s characterized by an itchy scalp, flakiness, and red, greasy patches. Causes include pollution, sedentary lifestyle, and chemical hair styling products. Prevalence is estimated at 60.1% in South Asia and 50% worldwide.
Existing treatments have limited success and may cause allergic reactions. Ayurvedic formulations offer a potential solution. The traditional line of treatment includes Kustaghna, Keshya, Kapha-Vatahara, Twachya, and Balyam. Priyala Beejadi Lepa is a proven treatment, but has limitations.
This study aims to evaluate the effectiveness of Priyala Beejadi shampoo versus Priyala Beejadi Lepa in managing Danuraka (dandruff). |