| CTRI Number |
CTRI/2022/02/039913 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
25/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
ASSESSMENT OF CUASITIVE FACTORS IN MELASMA |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO EVALUATE DOSHA PRAKOPA NIDANA IN VYANGA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vani Nayak |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Roga Nidana and Vikriti Vignana Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Tanniruhalla B M Road Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7892197370 |
| Fax |
|
| Email |
ivaninayak007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopikrishna S |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Roga Nidana and Vikriti Vignana Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Tanniruhalla B M Road Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9449664358 |
| Fax |
|
| Email |
gopikrishna1611979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopikrishna S |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Roga Nidana and Vikriti Vignana Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Tanniruhalla B M Road Hassan
KARNATAKA
573201
India |
| Phone |
9449664358 |
| Fax |
|
| Email |
gopikrishna1611979@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan B M Road Tanniruhalla Hassan 573201 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
B M Road Tanniruhalla Hassan Karnataka India 573201 |
| Type of Sponsor |
Private medical college |
|
|
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 Vani Nayak |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
IPD AND OPD IN Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan B M Road Tanniruhalla Hassan Karnataka India 573201
Hassan
KARNATAKA |
7892197370
ivaninayak007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital B M Road Tanniruhalla Hassan Karnataka India 573201 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals irrespective of gender between the age group of 18 to 60 years will be selected for study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation of causative factor in vyanga, at any point of time |
evaluation of causative factor in vyanga,One Time Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Finding relation between causative factor and vyanga no secondary outcome assessing |
Finding relation between causative factor and vyanga one time assessment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/02/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Results of the study will be published in approved journal after study
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The impact of dermatological diseases cause significant non fatal disability worldwide that contribute to be the 4th leading cause of non fatal disease burden . 44 Kshudra Rogas have been mentioned in classics and Vyanga ( melasma) is one among them explained with the prevalence rate of 2.125%. Vyanga affects the second layer4 of Twak (skin) and is characterised by Neeruja (painless), Tanu (thin lesion) and Shyava Varnayukta Mandala (dark brown circular lesion) on face. Based on its clinical features it can be simulated with melasma.. Vyanga (Kshudra Roga) due to its facial involvement makes high psychosocial impact in society and thus cannot be neglected. Hetu (Etiological Factors) are responsible for causation of any disease and can be classified into Dosha, Vyadhi and Ubhaya Prakopaka Hetu. Successful response to treatment depends upon proper understanding about Hetu. Thus in the present study an attempt will be made to evaluate the Dosha Prakopaka Hetu in Vyanga by using specially designed questionnaire on Dosha Prakopaka Hetu . |