| CTRI Number |
CTRI/2025/02/080544 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Abhyanga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study and compare the effectiveness of Malatyadi Tail and Kantakari Phala Rasa Siddha Tail Shiroabhyanga in Management of Darunak (Dandruff). |
|
Scientific Title of Study
|
Randomized Comparative Clinical Study on The Effectiveness of Malatyadi Tail with Kantakari Phala Rasa Siddha Tail Shiroabhyanga in Management of Darunak(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 |
Dr Priyanka Shyamrao Ghonge |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No. 18, Swasthvritta and Yoga Department,Vidarbha Ayurved Mahavidyalaya and Hospital,Dhanvantari Nagar,Amravati
Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
7350534557 |
| Fax |
|
| Email |
priyankaghonge11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay K Chopkar |
| Designation |
Guid and HOD Department of Swasthavritta and Yoga |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No. 18, Swasthvritta and Yoga Department,Vidarbha Ayurved Mahavidyalaya and Hospital,Dhanvantari Nagar,Amravati
Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9423105104 |
| Fax |
|
| Email |
skchopkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Shyamrao Ghonge |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No. 18, Swasthvritta and Yoga Department,Vidarbha Ayurved Mahavidyalaya and Hospital,Dhanvantari Nagar,Amravati
Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
7350534557 |
| Fax |
|
| Email |
priyankaghonge11@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No. 18, Swasthvritta and Yoga Department,Vidarbha AyurvedMahavidyalaya and Hospital,Dhanvantari Nagar,Amravati
Amravati
MAHARASHTRA
444605
India |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati 444605 |
| 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 Priyanka Shyamrao Ghonge |
Vidarbha Ayurved Mahavidyalaya |
OPD 18, Swasthavritta and Yoga Department,Vidarbha Ayurved Mahavidyalaya, Amravati
Amravati
MAHARASHTRA |
7350534557
priyankaghonge11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.H.V.P.M. Vidarbha Ayurved Mahavidyalaya, Amravati |
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 | Procedure | - | Siro~aBya~ggaH, शिरोरऽभ्यंग | (Procedure Reference: Ashtang sangrah sutra sthan 3, Procedure details: Shiroabhyang is one of the bahirparimarjan chikitsa forkhalitya the procedure can be explain as follows:
1) Purvakarma-The patient was made to sit on kneehigh chair, the body of the patient was wrapped by cloth. The procedure was followed by standing behind the patient; it is the procedure for Shiroabhyang.
2) Pradhankarma-The technique included smearing the Malatyadi Tail (oil) to the scalp above the neck with specific strokes were placed Take 10 ml of Malatyadi Tail and start Shiroabhyanga by following steps:
Gharshan Hasta- After smearing the oil massages the whole head and the neck moving the palmer surface of the hand from front to backwards applying gentle as well as firm.
Mridvanguli tadana- Fingers of the both hands moved as if picking tuff of hair, the fingers were partially approximated and then gently and firmly placed on scalp.Dvihasta tadana-gentle strokes were given the palmer surface on the scalp with both hands. Strokes were followed on vertex, occipital and temporal region.
Mridumushti Tadana-in this gentle stroke placed on all over head with the closed fist through ulnar border.
Ghatita hasta: Flat palm were placed on head and moulded into the shape of scalp so that every portion of the palmer aspect of palm and finger comes in contact of head.
3) Pachatkarma- then patient asked to take rest. Thenadvised to take head bath and wash hair with lukewarm water.)
(1) Medicine Name: Malatyadi Tail , Reference: Bhaishajya Ratnavali kshudrarogadhikar 60/137-138, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 2 Months | | 2 | Comparator Arm | Procedure | - | Siro~aBya~ggaH, शिरोरऽभ्यंग | (Procedure Reference: Ashtang sangrah sutra sthan 3, Procedure details: Shiroabhyang is one of the bahirparimarjan chikitsa forkhalitya the procedure can be explain as follows:
1) Purvakarma-The patient was made to sit on kneehigh chair, the body of the patient was wrapped by cloth. The procedure was followed by standing behind the patient; it is the procedure for Shiroabhyang.
2) Pradhankarma-The technique included smearing the oil to the scalp above the neck with specific strokes were placed. Take 10 ml of Kantakari Phala Rasa Siddha Tail & start Shiroabhyanga by following steps:
Gharshan Hasta- After smearing the oil massages the whole head and the neck moving the palmer surface of the hand from front to backwards applying gentle as well as firm.
Mridvanguli tadana- Fingers of the both hands moved as if picking tuff of hair, the fingers were partially approximated and then gently and firmly placed on scalp.Dvihasta tadana-gentle strokes were given the palmer surface on the scalp with both hands. Strokes were followed on vertex, occipital and temporal region.
Mridumushti Tadana-in this gentle stroke placed on all over head with the closed fist through ulnar border.
Ghatita hasta: Flat palm were placed on head and moulded into the shape of scalp so that every portion of the palmer aspect of palm and finger comes in contact of head.
3) Pachatkarma- then patient asked to take rest. Thenadvised to take head bath and wash hair with lukewarm water.)
(1) Medicine Name: Kantakari Phala Rasa Siddha Tail , Reference: Yog Ratnakar kshudrarogadhikar , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject having age group 18 to 50 years irrespective of
their gender, caste, marital status & economic class. 2. Patient having classical sign & symptoms of Darunak.
3. Kandu (itching on scalp)
4. Keshchyuti (Hair loss).
5. Rukshata (Dryness of scalp).
6. Raag (redness on scalp).
7. Daah (burning sensation on scalp). |
|
| ExclusionCriteria |
| Details |
1. Subject having history of any other general systemic
illness. 2. Subject on any other medication. 3. Subject taking any other treatment for same complaint
at same time 4. Seborrhic dermatitis, eczema,psoriasis patients. 5. Cancer patients and patients who are on chemotherapy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete remission from darunak (Dandruff)
Marked improvement in darunak (Dandruff)
Mild improvement in darunak (Dandruff) |
0th day
7th day
15th day
30th day
45th day
60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission from all kind of darunak
Healthy scalp established |
30th day
45th day
60th day |
|
|
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)
|
20/02/2025 |
| 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="0"
Months="8"
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
|
A randomised comparative clinical trial will be conducted to Study the effectiveness of Malatyadi Tail and Kantakari Phala Rasa Siddha Tail Shiroabhyanga in Management of Darunak (Dandruff)
Trial will be conducted in our institute and its periphery.
Total 120 patients having dandruff with by ASFS criteria (Adherent Scalp Flaking Score) will be Selected and then will be divded in two groups.
One group will be given Malatyadi Tail and other group will be given Kantakari Phala Ras Siddha Tail Shiroabhyanga for darunak.
The study will be done for 60 days. Results will be compared.
Data analysis will be done by using appropriate statistical test. Primary outcome will be to study the effectiveness of Malatyadi Tail and Kantakari Phala Rasa Siddha Tail in Darunak (Dandruff) patients complete, moderate and mild remission of dandruff in patients. |