CTRI Number |
CTRI/2021/01/030491 [Registered on: 15/01/2021] Trial Registered Prospectively |
Last Modified On: |
14/01/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) [Ghan vati] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Study of efficacy of Nishadi Ghana Vati and Karanja tail local application in skin disease |
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Nishadi Ghana Vati and Karanja Tail local
application in the management of Vicharchika with special reference to Eczema |
Trial Acronym |
RCTNK |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Manisa Singh |
Designation |
PG SCHOLAR |
Affiliation |
Government Ayurved College, Vazirabad, Nanded |
Address |
Kayachikitsa Department, Government Ayurved College, Vazirabad,
Nanded,
Maharashtra
India
Nanded MAHARASHTRA 431601 India |
Phone |
8339065877 |
Fax |
|
Email |
manisasingh688@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mangesh Nalkande |
Designation |
Assistant Professor |
Affiliation |
Government Ayurved College, Vazirabad, Nanded |
Address |
Kayachikitsa Department, Government Ayurved College, Vazirabad,
Nanded, Maharashtra
India
Nanded MAHARASHTRA 431601 India |
Phone |
9766694490 |
Fax |
|
Email |
mwnalkande@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mangesh Nalkande |
Designation |
Assistant Professor |
Affiliation |
Government Ayurved College, Vazirabad, Nanded |
Address |
Kayachikitsa Department, Government Ayurved College, Vazirabad,
Nanded, Maharashtra
India
MAHARASHTRA 431601 India |
Phone |
9766694490 |
Fax |
|
Email |
mwnalkande@gmail.com |
|
Source of Monetary or Material Support
|
Own funded,Kayachikitsa Department , Government Ayurved College , Vazirabad,Nanded |
|
Primary Sponsor
|
Name |
Manisa Singh |
Address |
PG Kayachikitsa Department, Government Ayurved College, Vazirabad,Nanded |
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 |
Manisa Singh |
Government Ayurved Hospital, Vazirabad, Nanded |
OPD NO.18
Kayachikitsa Department, Government Ayurved Hospital, Vazirabad,
Nanded, Maharashtra
431601 ,India Nanded MAHARASHTRA |
8339065877
manisasingh688@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee,GAC Nanded |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Arogyavardhini Vati and Karanja tail |
Arogyavardhini Vati 500mg BD orally after meal with Karanja tail for local application |
Intervention |
Nishadi Ghana Vati and Karanja Tail |
Nishadi Ghana Vati 500mg BD orally after meal with Karanja Tail local application for 30 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
The patient will be diagnosed on the basis of Symptoms of Vicharchika(Eczema) given in Sushruta Samhita
a) Mandala (patches)
b) Atikandu (severe itching)
c) Ruja (pain)
d) Rukshata (dryness)
Patients who are co-operative and ready to give written consent
Duration of symptoms is 1 year
|
|
ExclusionCriteria |
Details |
Patients having skin disorder other than eczema
Eczema with systemic illness like severe DM, IHD
Complicated or steroid dependent Eczema |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Decrease in itching, pain, dryness of lesion and decrease in size of 1 or 2 large lesions |
30days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nishadi Ghana Vati orally with Karanja Tail local application is more effective than Arogyavardhini Vati orally with Karanja Tail local application |
In 31 days |
|
Target Sample Size
|
Total Sample Size="33" Sample Size from India="33"
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)
|
20/01/2021 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
20/01/2021 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
This study will be submitted in the form of dissertation to Maharashtra University Of Health Sciences as a part of Post Graduation course |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This study is Randomized, controlled clinical study of Nishadi Ghana Vati 500mg BD orally after meal with Karanja Tail local application for 30 days and follow up on 0th, 16th and 31th day.This study is conducted as PG course at single centre.The primary outcome is decrease in itching, pain, dryness of lesion and decrease in size of 1 or 2 large lesion |