| CTRI Number |
CTRI/2025/03/082371 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial to find out the efficacy of head massage and blood letting in the management of Dandruff |
|
Scientific Title of Study
|
A Comparative Clinical Trial to find out the efficacy of Shiroabhyang and Siravedha in the management of Darunaka (Seborrheic Dermatitis)
|
| 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 Jaskirat Kaur |
| Designation |
Ayurvedic Medical officer(Punjab Govt.) , PhD Scholar |
| Affiliation |
Guru Ravidas Ayurved University, Hoshiarpur Medical officeer |
| Address |
OPD No 1
Government Ayurvedic Dispensary , Jalal Usman, Amritsar, PUNJAB
143114
INDIA
VPO.Kharkan, Una Road, Hoshiarpur, Punjab
1461101
India
Amritsar
PUNJAB
143114
India |
| Phone |
8360938403 |
| Fax |
|
| Email |
jaskiratk131@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Sharma |
| Designation |
Lecturer |
| Affiliation |
Guru Ravidas Ayurved University, HOSHIARPUR |
| Address |
OPD no 7
Dept of kayachikitsa
Govt Ayurvedic College and hospital Patiala
PUNJAB
147001
INDIA
Patiala
PUNJAB
147001
India |
| Phone |
9464259162 |
| Fax |
|
| Email |
ps61204@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Sharma |
| Designation |
Lecturer |
| Affiliation |
Guru Ravidas Ayurved University, HOSHIARPUR |
| Address |
OPD no 7
Dept of kayachikitsa
Govt Ayurvedic College and hospital Patiala
PUNJAB
147001
INDIA
Patiala
PUNJAB
147001
India |
| Phone |
9464259162 |
| Fax |
|
| Email |
ps61204@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Ravidas Ayurved University
Una Rd, VPO, Kharkan, Hoshiarpur, Punjab 1461101
India |
|
|
Primary Sponsor
|
| Name |
Dr Jaskirat Kaur |
| Address |
Govt Ayurvedic Dispensary Usman, Punjab 143114 |
| 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 Jaskirat Kaur |
Govt Ayurvedic Dispensary |
Ayurvedic Department
OPD no 1
VPO jalal Usman, Amritsar Punjab 143114
India
Amritsar
PUNJAB |
8360938403
jaskiratk131@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Ravidas Ayurved University Punjab (GRAUP) Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Su/Ch 20/30, Procedure details: 2 sittings of Siravedh to be done from cubital fossa at interval of 15 days with 22 no scalp vein and each time 20-30 ml of blood will be extracted)
(1) Medicine Name: Triphaladdi oil, Reference: BR 60/126, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 45 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi oil, Reference: BR 60//126, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -Apply taila at bed time |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
No major systemic disease involved
Dandruff restricted to the scalp with itchy, flaky skin without visible inflammation.
assessed by mean total Seborrheic Dermatitis Area Severity Index (SDASI) |
|
| ExclusionCriteria |
| Details |
skin diseases like psoriasis, atopic dermatitis, pregnancy,lactation, immunodeficiency states and hypersensitivity.
Patients with inflammatory or infective scalp, Thyroid, DM |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameter:
Distribution of flakes and No of Flakes will be studied according to DLQI and SDASI scale.
Objective Parameterrs
CBC
KOH Mount test
Trichoscopic Study
|
to study Darunaka Before intervention of Triphaladi oil application and Siraveddh. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/a |
N/a |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
24/03/2025 |
| 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="1"
Days="1" |
|
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
|
PLAN OF STUDY 1. Literary study: Vedic literature, Upanisada, Purana, Samhita of Ayurveda, commentaries and other texts of Ayurveda. Contemporary books, Retrospective studies, Journals, Magazines and Periodicals, Websites etc. 2. Clinical Study-Study Design • An open labelled, randomized, parallel group. 13 • Prospective study: The proposed trial is an interventional study which attempts to test the trial drugs on selected group of patients with comparison of Siravedha. • Study Type: Interventional • Allocation: Randomized • Masking: open • Assignment: Parallel assignment with simple random sampling by chit method • Timing: Prospective • End Point: Efficacy Study Clinical study • Materials for clinical study • A) Drugs-Triphaladi oil • B) Instruments- Scalp vein 22 no • C) Site of Siravedha: Vein of cubital fossa • Trichoscope • 120 subjects diagnosed with classical sign and symptoms of Darunakav |