| CTRI Number |
CTRI/2024/09/073242 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurveda medicine application in management of dandruff |
|
Scientific Title of Study
|
Effect of Madanphala Valkal Lepa in the management of Darunaka with special reference to Dandruff( Pityriasis capitis) A randomised controlled clinical trial. |
| 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 vikash sharma |
| Designation |
Pg scholar |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidhalaya Shahpur Belagavi |
| Address |
Department of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidhalaya Shahpur Belagavi
Belgaum
KARNATAKA
590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
8708185400 |
| Fax |
|
| Email |
vs008051@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita S Angadi |
| Designation |
HOD and Professor |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidhalaya Shahpur Belagavi |
| Address |
Department of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidhalaya Shahpur Belagavi
Belgaum
KARNATAKA
590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
7411213286 |
| Fax |
|
| Email |
savitaangadi484@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita S Angadi |
| Designation |
HOD and Professor |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidhalaya Shahpur Belagavi |
| Address |
Department of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidhalaya Shahpur Belagavi
Belgaum
KARNATAKA
590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
7411213286 |
| Fax |
|
| Email |
savitaangadi484@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri BMK Ayurveda Mahavidhyalaya and Hospital Shahapur Belagavi |
|
|
Primary Sponsor
|
| Name |
vikash sharma |
| Address |
Department of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidhalaya Shahpur Belagavi
Belgaum
KARNATAKA
590003 India |
| 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 vikash sharma |
KAHERS Shri BM Knakanwadi Ayurveda Mahavidyalaya and Hospital |
Room no 26 and 27 Department of Shalakya tantra Belgaum KARNATAKA
Belgaum
KARNATAKA |
8708185400
vs008051@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L308||Other specified dermatitis. Ayurveda Condition: L21.0, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amrabeejharitaki lepa, Reference: Jadhav, Shubhangi. (2023). RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE ROLE OF AAMRABEEJA-HARITAKI LEPA. International Ayurvedic Medical Journal. 3. 429-433., Route: Topical, Dosage Form: Lepa Churna, Dose: 40(g), Frequency: sos, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madalphala valkal lepa, Reference: Sidha yoga chapter 57 Kshudra roga adhikar verses 94 , Route: Topical, Dosage Form: Lepa Churna, Dose: 35(g), Frequency: sos, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
subject presenting with classical features of
darunaka as mentioned in diagnostic criteria will be selected they are
itching on scalp kandu
hair fall keshachyuti
dryness of scalp rukshana
scaling of scalp twaksphutana |
|
| ExclusionCriteria |
| Details |
Associated with other dermatological conditions such as psoriasis.
Subject having Chronic infectious disease (tuberculosis, leprosy)
Other types of Kapalagata rogas like Arumshika |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of darunaka which are scaling of scalp, itching, dryness will be assessed |
Baseline, 15th day, 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
03/12/2024 |
| 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
|
Pityriasis capitis is a non-inflammatory disease of scalp with itching, visible flakes and hair fall. Post pubertal population (aged 18 to 60) is the most vulnerable age group to this issue. It has been noted that all population across the globe eventually develop Pityriasis capitis at least once in their lifetime .1 As there are many Anti Pityriasis capitis formulations in the market with chemical composition like ketoconazole 2% solution which is having side effect like hair loss, paresthesia, rashes, gynaecomastia. 2 As these drugs are chemical based, having many side effect . Hence there is need of effective treatment for Darunaka. In Ayurveda Pityriasis capitis can be correlated with Darunaka which is kaphaj-vataj condition having symptoms like Kandu, Gaurava, Keshachyuti, Daruna Swapa,Rukshata, Twak sphutana, Toda ,Daha and Raga. 3 Darunaka Chikitsa sutra refers for different treatment modalities like siramokshana,nasya, sirobasti, lepa and shiroabhyanga. 4 In classics lepa application is said for darunaka like Amrabeejmajjadi lepa , Khaskhasbeejadi lepa, Amalakiadi lepa, Madanaphala valkal lepa etc. Madanaphala valkal lepa has Vata and Kaphahara properties like lekhaneya, shothaghna, kusthaghna etc. Hence this study is planned with Madanaphala valkal lepa .
|