| CTRI Number |
CTRI/2022/02/040369 [Registered on: 17/02/2022] Trial Registered Prospectively |
| Last Modified On: |
07/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE THE EFFECT OF MALATHYADI TAILAM AND KETOCONAZOLE SHAMPOO IN DANDRUFF. |
|
Scientific Title of Study
|
Randomaized comparative clinical study to evaluate the efficacy of malathyadi tailam shiroabhyanga (head massage) as compared to ketoconazole shampoo in the management of darunak (dandruff). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajakta Korde |
| Designation |
M.D. Scholar Panchakarma |
| Affiliation |
DR. D. Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE, SANT TUKARAM NAGAR, PIMPRI, PUNE. |
| Address |
Department of panchakarma opd no 9 Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411 018
India |
| Phone |
7747047664 |
| Fax |
|
| Email |
prajakta.korde48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mamata Nakade |
| Designation |
MD PhD Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center |
| Address |
Department of panchakarma opd no 9 Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850241887 |
| Fax |
|
| Email |
mamtaraut1966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prajakta Korde |
| Designation |
M.D. Scholar Panchakarma |
| Affiliation |
DR. D. Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE, SANT TUKARAM NAGAR, PIMPRI, PUNE. |
| Address |
Department of panchakarma opd no 9 Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7747047664 |
| Fax |
|
| Email |
prajakta.korde48@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.D.Y.Patil College of Ayurved And Research Centre |
|
|
Primary Sponsor
|
| Name |
Prajakta Korde |
| Address |
Department of panchakarma opd no 9 Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
411018 |
| 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 Prajakta Korde |
DR. D. Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE, |
Department of panchakarma OPD no 9
Pune
MAHARASHTRA |
7747047664
prajakta.korde48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instiitutional Ethics Comittee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L821||Other seborrheic keratosis. Ayurveda Condition: DARUNAKAH, (2) 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 | - | Shiroabhyanga | (Procedure Reference: A.H su 22/24, Procedure details: 30 min for 15 days shiroabhayanga (head masaage))
| | 2 | Comparator Arm (Non Ayurveda) | | - | Ketconazole shampoo | Twice a week 5 minutes for 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of age between 20 to 60 years irrespective of sex, religion, and occupation
2)patient showing classical symptoms of darunaka like kandu, twak sfutan, keshchyuti and rukshata.
3) Patients willing to sign the consent for the study. |
|
| ExclusionCriteria |
| Details |
1) patients with other major physical illnesses viz. IHD, malignancy HIV, etc.
2) patients suffering from other hair diseases like psoriasis of the scalp, eczema of the scalp, head injury in which head bath wash is restricted, ringworm infestation to the scalp, ardita.
3)patients with severe hair fall like indralupta |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficancy of malathyadi tailam shiroabhyanga (head massage) in the management of darunaka ( dandruff ) |
15 days
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction of itching and dryness |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is the clinical study to evaluate the efficacy of malathyadi tailam shiroabhyanga( head massage) as compared to ketoconazole shampoo in the management of darunaka (dandruff). The study design is a randomized comparative clinical study. total 60 patients will be enrolled Group A (30 patients) - will be given malathyadi tail shiroabhyang (head massage) for 7 days. Group B (30 patients) - will be given ketoconazole shampoo twice a week for 7 days. Two follow-ups will be there on the 7th and 14th day The total duration of the study will be 18 months. |