| CTRI Number |
CTRI/2018/04/013263 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study of effect of kumkumadi ghee by Errhine therapy in Acne |
|
Scientific Title of Study
|
Evaluation of Nasya with Kumkumadi Ghruta in Mukhadushika(Acne Vulgaris) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
priyanka kapse |
| Designation |
PG scholar |
| Affiliation |
BVDU College of Ayurved and Hospital |
| Address |
Department of Panchakarma
BVDU College of Ayurved
Dhankawadi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9028835829 |
| Fax |
|
| Email |
drpriyankabirajdar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
priyanka kapse |
| Designation |
PG scholar |
| Affiliation |
BVDU College of Ayurved and Hospital |
| Address |
Department of Panchakarma
BVDU College of Ayurved
Dhankawadi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9028835829 |
| Fax |
|
| Email |
drpriyankabirajdar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula Matekar |
| Designation |
Assistant Professor |
| Affiliation |
BVDU College of Ayurved and Hospital |
| Address |
Department of Panchakarma
BVDU College of Ayurved
Dhankawadi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9422022739 |
| Fax |
|
| Email |
manjulamatekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University College of Ayurveda Dhanakwadi Pune 43 |
|
Primary Sponsor
Modification(s)
|
| Name |
self |
| Address |
BVDU college of Ayurved pune |
| 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 |
| Priyanka Kapse |
Bharati Vidyapeeth Ayuved Hospital |
Department of Panchakarma
Bharati vidyapeeth Ayurveda Hospital Dhankawadi Pune
Pune
MAHARASHTRA |
7517890909
drpriyankabirajdar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| B.V.D.U College Of Ayurved Pune- 411043 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, Patients Having Acne Vulgaris and comes under inclusive criteria , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluation of Kumkumadi Ghrita Nasya in Mukhadushika (Acne Vularis) |
Nasya (Errhine therapy)With Kumkumadi Ghruta with 4 Drops is calclulated as 2 ml in each Nostril for 7 days to reduce the symptoms of Acne vularis |
| Comparator Agent |
not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Both |
| Details |
Patients fit for Nasya(Errhine Therapy)
Patints with Signs and symptoms of Mukhadushika (Acne Vulgaris) Viz Comedones,Papules,pustules ,nodules |
|
| ExclusionCriteria |
| Details |
Pregnant Women and lacteting mother
patients suffering from secondary skin disease like psoriasis,Vitiligo |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient relieve from all sign and symptoms of Mukhadushika comedones,papules,pustules, nodules in 7 days |
Patient relieve from all sign and symptoms of Mukhadushika comedones,papules,pustules, nodules in 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observed all sign and symptoms of Muhkadushika for 1 month |
Access all signs and symptoms of Mukhadushika after 7 days of nasya, then after 15 days and 1 month from the first day of the treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
12/10/2017 |
| 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="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Now a days due to changing food habits ,changing lifestyle Mukhadushika (Acne Vulgaris) is very commen skin disease in adolescence as well as people in twenties & thirties also. Mukhadushika is a disease which harms the beauty of face typically during the adolescence, it is the age when all are most conscious about their beauty hence it has an impact on persons physical,social,&psychological life.Kumkumadi ghruta which have constituents kumkum,Haridra, Daruharidra,pippali, chitrak,gou ghruta are kapha,vata hara properties,and tvakvaimalyakara,which breaks the pathogenesis of Mukhadushika and drug administered through nasal route acts on Urdhvajatrugata area and removes the dushta dosha specially Khapha and acts as tvakvaimalyakara .
About procedure:- | Particular | Procedure | | No of Patients | 30 | | Treatment given | Nasya(Errhine therapy) | | Dose | 4 Drops in each nostril (2ml) |
| Duration | 7 days | | Time | After Break fast (10-11am) | | purvakarma | Urdhvajatrugata Pradeshi Abhyanga & Tap Sweda | | Pradhankarma | Kumkumadi Ghruta Nasya | | Pashchatakarma | Gandusha With Koshna Jala |
|