| CTRI Number |
CTRI/2023/08/056185 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/08/2023 |
| 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
|
Mahanimba Taila used for Sthanika Abhyanga and Nasya with Keshavardhini Rasayana for the management of Indralupta. |
|
Scientific Title of Study
|
A Clinical Study to evaluate the effect of Mahanimba taila Nasya with Sthanika Abhyanga and Keshavardhini Rasayana sevana in the management of Indralupta W.S.R to Alopecia areata.(Randomised comparative clinical study) |
| 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 Kavana K |
| Designation |
PG Scholor |
| Affiliation |
Dhanvantari Ayurveda College, Hospital and Research Center.Siddapur.(U.K) |
| Address |
Department of PG studies in Panchakarma. Dhanvantari Ayurveda College,Hospital and Research Center,Sirsi road,Siddapur(U.K.)
Department of PG studies in Panchakarma.Dhanvantari Ayurveda College,Hospital and Research Center,Sirsi road, Siddapur(U.K.)
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9986329290 |
| Fax |
9986329290 |
| Email |
kavanavinayjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kulkarni Ashwini A |
| Designation |
Head of the department, Professor |
| Affiliation |
Dhanvantari Ayurveda College, Hospital and Research Center.Siddapur.(U.K) |
| Address |
Department of P.G Studies in Panchakarma
Dhanvantri Ayurveda College Hospital And PG Research Centre,Siddapur(U.K)
Department of P.G Studies in Panchakarma
Dhanvantri Ayurveda College Hospital And PG Research Centre,Siddapur(U.K)
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
8879044624 |
| Fax |
8879044624 |
| Email |
ashwini.kulkarni15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kulkarni Ashwini A |
| Designation |
Head of the department, Professor |
| Affiliation |
Dhanvantari Ayurveda College, Hospital and Research Center.Siddapur.(U.K) |
| Address |
Department Of PG Studies in Panchakarma
Dhanvantari Ayurveda College,Hospital And Research Centre,Sirsi road,Siddapur (U.K)
Department Of PG Studies in Panchakarma
Dhanvantari Ayurveda College,Hospital And Research Centre,Sirsi road,Siddapur (U.K)
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
8879044624 |
| Fax |
8879044624 |
| Email |
ashwini.kulkarni15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanvantari Ayurveda College,Hospital and Research Centre.Siddapur(U.K.)Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Kavana K |
| Address |
Dhanvantari Ayurveda College,Hospital and PG Research Center,Siddapur (U.K.) Karnataka |
| 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 Kavana K |
Dhanvantari Ayurveda Hospital |
Department of Panchakarma,OPD no.07.
Uttara Kannada
KARNATAKA |
9986329290
kavanavinayjoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dhanvantari Ayurveda College,Hospital and Research Center,Siddapur-581355(Uttara Kannada)Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astangasangraha Sutrasthana, Procedure details: Nasya Karma will be done once daily for 7 days per month for 3 months.)
(1) Medicine Name: Mahanimba Taila, Reference: Nighantu Adarsha, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 5(ml), Frequency: od, Duration: 3 Months(2) Medicine Name: Keshavardhini Rasayana, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 3 Months | | 2 | Comparator Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Bruhatrayi, Procedure details: Abhyanga will be done on the affected part for 30 to 40 mins per day twice daily for 3 months.
)
(1) Medicine Name: Mahanimba taila, Reference: Nighantu Adarsha, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: bd, Duration: 3 Months(2) Medicine Name: Keshavardhini Rasayana, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients With Lakshanas Of INDRALUPTA
2.Patients Of age group between 16 to 60 years will be included irrespective of their gender,religion ,marital status and Socioeconomic status
3.Patients fit for STHANIKA ABHYANGA and NASYA KARMA
4.Localised hair loss in areas of scalp, beard,mustache |
|
| ExclusionCriteria |
| Details |
1.Patients less than 16 and above 60 years of age
2.Patients having hereditary baldness or having history of hair loss due to injury
3.Patients suffering from any severe systemic disease
4.Patients unfit for STHANIKA ABHYANAGA and NASYA KARMA
5.ALOPECIA TOTALIS AND ALOPECIA UNIVERSALIS CASES |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The total number of patches will be counted,size of patches will be measured.The hair growth will be assessed. |
0TH,30TH,60TH,90TH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Total no. of patches,size of patches reduced or aggrevated will be counted & measured. |
60th,90TH day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
13/08/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
STUDY TYPE : Randomised Comparative Clinical Study, Pre and post test study, Timing-Prospective, Masking - Open label, Grouping - Double arm, Randomisation- Computer generated, Group intervention method-Parallel In two groups of Indralupta patients, the effect of Mahanimba Taila Sthanika abhyanga with and without Nasya karma along with Keshavardhini Rasayana Sevana will be compared. |