| CTRI Number |
CTRI/2025/03/081496 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Efficacy Of Darunaka Yog Lepa & oil in Management of Dandruff patients |
|
Scientific Title of Study
|
Pharmacognostical, Antimicrobial (In-Vitro) Study & Clinical efficacy of Darunaka Yog (Priyala, Yashtimadhu, Kushta, Masha, Sarsapa) Lepa & oil in Management of Darunaka (Pityriasis capitis) |
| 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. Amrit Jindal |
| Designation |
PG RESIDENT |
| Affiliation |
Ayurveda and Unani tibbia college |
| Address |
Department of Dravyaguna vigyan Ayurveda and Unani Tibbia College New Delhi, Karolbagh, New Delhi
Central
DELHI
110005
India |
| Phone |
7011028414 |
| Fax |
|
| Email |
7011aj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sharma |
| Designation |
Professor |
| Affiliation |
Ayurvedic & Unani Tibbia College & Hospital |
| Address |
Dravyaguna Department, Ayurvedic & Unani Tibbia College & Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9868092250 |
| Fax |
|
| Email |
rajsakshi.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Sharma |
| Designation |
Professor |
| Affiliation |
Ayurvedic & Unani Tibbia College & Hospital |
| Address |
Dravyaguna Department, Ayurvedic & Unani Tibbia College & Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9868092250 |
| Fax |
|
| Email |
rajsakshi.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dravyaguna Ekal Dravya OPD 18 Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi Delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic Unani Tibbia College |
| Address |
Ayurvedic & Unani Tibbia College Karol Bagh New Delhi Ajmal khan road karol bagh 110005 |
| Type of Sponsor |
Government medical college |
|
|
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 Amrit Jindal |
Dravyaguna Department Ayurvedic and Unani Tibbia College and Hospital |
Dravyaguna Department Ekal Dravya OPD No 18 Karol Bagh New Delhi 110005
Central
DELHI |
7011028414
7011aj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethical Committee AUTCH |
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: Darunaka Yog in the form of Oil, Reference: Astanga Sangrah Uttartantra 27/33, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: sos, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darunaka Yog in the form of Lepa, Reference: Astanga Sangrah Uttartantra 27/33, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: sos, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: NA, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having classical feature of darunaka like twakasphutan (Scaling of scalp), Kandu (itching), keshachyuti (loss of hair), and pitika on the scalp. Will be included.
2. Patients of any gender in the age group of 18 to 60yrs will be included.
3. Patients who are willing to participate and give written informed consent.
4. Patients not using any tipical treatment for dandruff for past 1 month. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant antimicrobial activity (In-vitro) of Darunaka Yog [Priyala (Buchanania lanzan Spreng), Yashtimadhu (Glycyrrhiza glabra Linn.), Kushta (Saussurea lappa C. B. Clarke), Masha (Vigna mungo), Sarsapa (Brassica campestris koch)] may be found |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant clinical efficacy of topical application of Darunaka Yog [Priyala (Buchanania lanzan Spreng), Yashtimadhu (Glycyrrhiza glabra Linn.), Kushta (Saussurea lappa C. B. Clarke), Masha (Vigna mungo), Sarsapa (Brassica campestris koch)] lepa & oil on darunaka (Pityriasis capitis) |
28 days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/03/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The prevalence of dandruff (Pityriasis capititis) is about -50% among the general population. In South Asia region has reported a greater prevalence of 60.1%.
In recent years there has been a considerable increase in the incidence of skin problems due to various reasons like poor sanitation and hygiene condition, population etc. Dandruff (pityriasis capititis) is one of the Kshudra roga/Shiro rog which affecting all the age group of population. It is a common cosmetic problem in today’s era. patients having fungal infection, treating with modern medicine, even through patients get relief but after stopping treatment disease reappears. The increase in prevalence of multiple drug resistance has slowed down the development of new synthetic antifungal drugs, antibacterial drugs and has necessitated the search for new antifungals & antibacterial from herbal sources. Antifungal & antibacterial drugs have many drawbacks, recurrence of disease is very common therefore we need to discover antifungal & antibacterial activity in herbal medicine.
To explore Anti-microbial property of Priyala (Buchanania lanzan Spreng), Yashtimadhu (Glycyrrhiza glabra Linn.), Kushta (Sassurea lappa C. B. Clarke), Masha (Vigna mungo), Sarsapa (Brassica campestris koch) Lepa in clinical study, it is necessitated to evaluate its antimicrobial activity (In-vitro).
Priyala (Buchanania lanzan Spreng), Yashtimadhu (Glycyrrhiza glabra Linn.), Kushta (Sassurea lappa C. B. Clarke) Masha (Vinga mungo), Sarsapa (Brassica campestris koch) Lepa in Astang sangrah and Hriday is said to be effective in darunaka. Pre- clinical & Clinical studies are still needed to be done, So this study is to evaluate Pharmacognostical, Antimicrobial & Clinical efficacy of Priyala (Buchanania lanzan Spreng), Yashtimadhu (Glycyrrhiza glabra Linn.), Kushta (Sassurea lappa C. B. Clarke), Masha (Vigna mungo), Sarsapa (Brassica campestris koch) Lepa in the management of Darunaka (Pityriasis capitis).
Antimicrobial Study of Yashtimadhu (Glycyrrhiza glabra Linn.) has already been done. |