| CTRI Number |
CTRI/2020/08/027067 [Registered on: 10/08/2020] Trial Registered Prospectively |
| Last Modified On: |
12/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trail to compare the effect two types of Nasya in Hyperpigmentation (Vyang) w.s.r.to Melasma |
|
Scientific Title of Study
|
“A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF NASYA IN VYANGA WITH SPECIAL REFRENCE TO MELASMA.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivaleela Kalyani |
| Designation |
Professor |
| Affiliation |
BVVS Ayurveda Medical College and HospitalBagalkot |
| Address |
Dr S.S Kalyani
MD(Ayu)
Professor
Department of Kayachikitsa
B.V.V.S Ayurveda medical college Bagalkot 587101
C/O Dr C R Honawad Morabad building cement factory road Bagalkot 587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
09591273858 |
| Fax |
|
| Email |
drleelakalyani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahantesh M Salimath |
| Designation |
Professor |
| Affiliation |
BVVS Bagalkot |
| Address |
BVVS Ayurveda Medical college and hospital Bagalkot-587101
BVVS Ayurveda Medical college and hospital Bagalkot 587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
9845010950 |
| Fax |
|
| Email |
bvvsamch2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivaleela Kalyani |
| Designation |
Professor |
| Affiliation |
BVVS Bagalkot |
| Address |
C/O R.C.Honawad Shivasmrutinilay Managuli layout Bagalkot
C/O Dr C R Honawad Morabad building cement factory road Bagalkot 587101
C/O Dr C R Honawad Morabad building cement factory road Bagalkot 587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
09591273858 |
| Fax |
|
| Email |
drleelakalyani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shivaleela kalyani |
| Address |
C/O Dr. C.R.Honawad Kempa road near cement factory road Bagalkot |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR S S KALYANI |
BVVS AMCH BAGALKOT |
C/O R.C.Honawad Shivasmrutinilay Managuli layout Bagalkot
C/O Dr C R Honawad Morabad building cement factory road Bagalkot 587101
Bagalkot
KARNATAKA |
09591273858
08354223280
drleelakalyani@gmail.com |
| DR S S KALYANI |
Parul Institute of Ayurveda, Parul University |
Post Limda, Waghodia, 391760
Vadodara
GUJARAT |
09591273858
drleelakalyani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL, BAGALKOT |
Approved |
| PARUL INSTITUTE OF AYURVED, PARUL UNIVERSITY, VADODARA. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kanaka taila Nasya |
Sl.No Chikitsa (Method of Administration) Aushadhi Kalpa Kala Matra
Group-A Nasya(Pratimarsa) Yastyadi Taila Taila 1st-30th day 2o in each nostril once in a day(morning)
Group-B Nasya(Pratimarsa) Kanaka Taila Taila
1st-30th day 2o in each nostril once in a day(morning)
|
| Intervention |
Yastyadi taila Nasya |
Sl.No Chikitsa (Method of Administration) Aushadhi Kalpa Kala Matra
Group-A Nasya(Pratimarsa) Yastyadi Taila Taila 1st-30th day 2o in each nostril once in a day(morning)
Group-B Nasya(Pratimarsa) Kanaka Taila Taila
1st-30th day 2o in each nostril once in a day(morning)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosed case of Vyanga and Melasma.
2) Patients with the age group between 18- 65years of either sex.
|
|
| ExclusionCriteria |
| Details |
1) Vyanga along with Kushta roga to be excluded.
2) Hyperpigmentation caused by tumor like malignant melanoma
3) Women using oral contraceptives
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameter
1. Mukhamaagatya mandalam (Circumscribed hyper pigmented patches on the face)
2. Neerujam (Painless patches)
3. Vaivarnya (Shyavam, Krishna,Tamra varnas) /Brownish pigment
4. Kandu (itching)
5. Parusha sparsha (Dry skin)
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective Parameters
MASI Score
|
No specific time |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/08/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vyanga
is one of the Kshudra Roga which produces marked
cosmetic disability and gives too much mental stress1. Vyanga is characterized by Niruja, Tanu, Shyava Varnayukta Mandala on Mukha Pradesha2. In this
study, Vyanga can be clinically
correlated to Melasma.
Melasma an acquired pigmentary disorder is characterized by Hyperpigmented
brown to grayish brown macules on the face. In India 20-30% of
40-65 years old women present a facial Melasma. It
occurs mainly in women 90% and 10% of male of all ethnic and racial groups3.
In contemporary science, treatment includes an
external application of creams containing hydroquinine and hydrocortisone,
which is found to be sensitive in few patients. These treatment modalities are
used frequently and for longer duration which is financial and social burden to
patient4.
Ayurveda relatively proved to be
efficacious in treatment of skin diseases. Acharyas
mentioned various therapeutic
procedures like Siravyadha, Lepa, Nasya etc In Vyanga Vata,Pitta
and Rakta Doshas get vitiated in Mukhapradesha. Here YastyadiTaila Nasya5 mentioned inYogachandrika, (Kshudraroga Chikitsa) & Kanaka Taila
nasya6 mentioned in Bhaishajya Ratnavali, (Kshudra Rogadhikara) ingredient’s
like Madhuka (Yastimadhu),
Shweta Chandan, Laksha, Kunkum,
Kaliyak, Ushir, Nyagrodha, Padmaka, Raktachandana, Nilotpal, Kinjalka, Patranga,
Tamravalli, Jatu, Nagakesra etc having the same properties like Madhura-Tikta Rasa & Sheeta Virya properties. So it acts as Raktaprasadaka, Twakprasadaka ,Varnyakaraka & Vatapittahara.
Hence present study is aimed to
evaluate the effect of Yastyadi Taila Nasya and Kanaka Taila Nasya in Vyanga Roga. |