| CTRI Number |
CTRI/2025/05/087141 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two forms of Sarivadya Oil and Gel to treat Dandruff along with analytical study |
|
Scientific Title of Study
|
A Pharmaceutico-analytical and Clinical evaluation of Sarivadya Taila to Sarivadya Gel in the management of Darunaka |
| 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 Bhanupriya S |
| Designation |
PG Scholar |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College |
| Address |
ALN Rao Memorial Ayurvedic Medical College
Department of Rasashastra and Bhaishajya kalpana
Kachkal road,Koppa
Chikmagalur,
Karnataka 577126
India
Chikmagalur KARNATAKA 577126 India |
| Phone |
9071872115 |
| Fax |
|
| Email |
drbhanupriya9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dinesh Kumar Mishra |
| Designation |
Professor |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College |
| Address |
ALN Rao Memorial Ayurvedic Medical College
Department of Rasashastra and Bhaishajya kalpana
Kachkal road,Koppa
Chikmagalur,
Karnataka 577126
India
Chikmagalur KARNATAKA 577126 India |
| Phone |
9448744577 |
| Fax |
|
| Email |
drdkmishra12@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhanupriya S |
| Designation |
PG Scholar |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College |
| Address |
ALN Rao Memorial Ayurvedic Medical College
Department of Rasashastra and Bhaishajya kalpana
Kachkal road,Koppa
Chikmagalur,
Karnataka 577126
India
Chikmagalur KARNATAKA 577126 India |
| Phone |
9071872115 |
| Fax |
|
| Email |
drbhanupriya9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Rasashastra and Bhaishajya kalpana
ALN Rao Memorial Ayurvedic Medical College Koppa, Chikmagalur
Karnataka 577126 |
|
|
Primary Sponsor
|
| Name |
Dr Bhanupriya S |
| Address |
Department of Rasashastra and Bhaishajya kalpana
ALN Rao Memorial Ayurvedic Medical College Koppa,
Chikmagalur
Karnataka 577126
|
| 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 Bhanupriya S |
ALN Rao Memorial Ayuevedic Medical College and Hospital Kachkal road Koppa |
Rasa shastra and Bhaishajya kalpana, Division A, room no.1 Chikmagalur KARNATAKA |
9071872115
drbhanupriya9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALN Rao Memorial Ayurvedic Medical College |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sarivadya Gel, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarivadya Taila, Reference: Gada nigraha, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with clinical signs of Darunaka as per Ayurvedic classics will be included.
2.Patients above the age group of 5years will be selected for the study.
3.Patients irrespective of sex, religion and occupation will be selected for the study. |
|
| ExclusionCriteria |
| Details |
1.Allergic manifestation.
2.Patients with other scalp disorders like Sidma, Indrlupta, Kitiba kusta.
3.Patients who were restricted from taking head bath like Asya roga, Karna roga , Netra roga.
4.Patients with Psychological disorders.
5.Patients with Systemic disease. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Scaling/crackling of skin
2. Itching
3. Dryness of scalp
4. Hairfall |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
15/06/2025 |
| 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="0" Months="0" Days="30" |
|
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
|
This is a pharmaceutico-analytical and clinical evaluation of Sarivadya taila to Sarivadya gel for 30 days. This study comprise of two groups of 30 subjects with Darunaka. Study will be conducted in ALN Rao Memorial Ayurvedic Hospital in Koppa Taluk, Chikamagalur district, Karnataka 577126. Primary outcome measures will be Scaling/crackling of skin , Itching, Dryness of scalp, Hairfall , Trichoscopy. |