| CTRI Number |
CTRI/2025/08/093268 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Malatyadi Tail Head Massage For Darunaka(Dandruff) |
|
Scientific Title of Study
|
Open Randomised Control Clinical Trial To Evaluate The Efficacy Of Malatyadi Tail Shiroabhyanga In 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 Kishori RajendraPatil |
| Designation |
MS Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Centre Ashta Sangli |
| Address |
OPD No 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta TAL Walwa Dist Sangli Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
8691862512 |
| Fax |
|
| Email |
Kishorirspatil3105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayvant Vasant Kharat |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Centre Ashta Sangli |
| Address |
OPD No 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta TAL Walwa Dist Sangli Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayvant Vasant Kharat |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Centre Ashta Sangli |
| Address |
OPD No 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta TAL Walwa Dist Sangli Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research centre Ashta Tal-Walwa Dist-Sangli Maharashtra 416301 India |
|
|
Primary Sponsor
|
| Name |
Dr Kishori Rajendra Patil |
| Address |
OPD No 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta TAL Walwa Dist Sangli |
| 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 Kishori Patil |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Centre Asht |
Department of Shalakyatantra OPD/ IPD Sangli Maharashtra
Sangli
MAHARASHTRA |
8691862512
Kishorirspatil3105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Hon Annasaheb Dange Ayurved Medical College And Post Graduate And Research Cetre Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Siro~aBya~ggaH, शिरोरऽभ्यंग | (Procedure Reference: Vagbhat Sutrasthana 22-23 24, Procedure details: The technique of shiro-abhyanga includes smearing the oil to the portions of
the scalp above the neck followed by placing specific strokes. The whole
procedure may be performed in the following steps for 5
minutes per day. For ex. Mridvanguli tadana, etc.)
(1) Medicine Name: Malatyadi tail, Reference: Chakradatta shudraroga adhyay 55/94, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | Siro~aBya~ggaH, शिरोरऽभ्यंग | (Procedure Reference: Vagbhat Sutrasthana 22-23 24, Procedure details: The technique of shiro-abhyanga includes smearing the oil to the portions of
the scalp above the neck followed by placing specific strokes. The whole
procedure may be performed in the following steps for 5
minutes per day. For ex. Mridvanguli tadana, etc.)
(1) Medicine Name: Gunjadi taila, Reference: Yogaratnakara uttartantra kshudrarogadhyay 90, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 The patients presenting with classical features of Darunaka as
mentioned in diagnostic criteria will be selected irrespective of their
Age, sex, education, religion,etc
2 Patients in the age group of 18-60 yrs.
3 Dandruff present on scalp only. |
|
| ExclusionCriteria |
| Details |
1) Patients having any serious systemic ,metabolic and infectious
diseases such as Any kind of malignancy, DM, Leprocy
2) Patients associated with chronic as well as inflammatory
dermatological conditions such as Seborrheic dermatitis, etc.
3) Pregnant women and lactating women.
4) Snehana karma contraindicated diseases for ex.Nawa jwar |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Malatyadi tail is effective in the management of Darunaka |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gunjadi tail is effective in the management of Darunaka |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
06/09/2025 |
| 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="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
|
Darunaka is the disease concerned with scalp and hair root and can be compared with pityriasis capitis commonly known as dandruff. Dandruff is a common chronic scaly disorder that is characterized by flacking of the skin of scalp.as skin cell dies, it shades from the scalp. However sometimes excessive flaking occurs with itching sensation, resulting in dandruff.Prevalence rate of dandruff in worldwide is about 50% Kandu (Itching), Keshacyuti (falling of hair), Swapa (abnormalities of touch sensation), Rukshata (roughness or dryness of the skin), Daruna (difficult in tolerance) and Twaksphutana (breaking or cracking of the skin) are the cardinal symptoms of the disease Darunaka Shiro-abhyanga is a type of snehana in which sneha is applied on the scalp, it comes under the classification of the Murdha Taila, which itself is a part of external Snehana.The technique of shiro-abhyanga includes smearing the oil to the portions of the scalp above the neck followed by placing specific strokes afterwards Dip a towel in a lukewarm water and wrap it around head. Patient is asked to take rest on the chair for about 15 minutes, and then they may be allowed to take head bath with lukewarm water. The trial drug Malatyadi tail is explained in the Chakradattas Chakrapani tika under Kshudraroga adhyay. In Malatyadi tail ,kalka is made up of Malati patra(chameli),Shuddha Karveer mula,Chitrak mula, Karanj beej.Siddha tail is made by it. This oil is specially made for abhyanga in Indralupta and Darunaka. |