| CTRI Number |
CTRI/2019/07/020266 [Registered on: 19/07/2019] Trial Registered Prospectively |
| Last Modified On: |
17/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to compare induced emesis(vomitting) effect of medicine like Madanaphala and Jimutaka in skin disease (psoriasis) |
|
Scientific Title of Study
|
A comparitive clinical study of Madanaphala and Jimutaka yoga in the management of Eka kushta w.s.r Psoriasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Imtiaz Hossain |
| Designation |
PG Scholar,Parul Institute Of Ayurved |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Panchakarma Dept,Parul Institute Of Ayurved,Parul University, P.O Limda,Waghodia, Dist Vadodara Gujrat-391760
Vadodara GUJARAT 391760 India |
| Phone |
9804822563 |
| Fax |
|
| Email |
imtiaz.dr2015@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amol Patane |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Panchakarma Dept,Parul Institute Of Ayurved,Parul University, P.O Limda,Waghodia, Dist Vadodara Gujrat-391760
Vadodara GUJARAT 391760 India |
| Phone |
9607175173 |
| Fax |
|
| Email |
amolpatane@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Md Imtiaz Hossain |
| Designation |
PG Scholar,Parul Institute Of Ayurved |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Panchakarma Dept,Parul Institute Of Ayurved,Parul University, P.O Limda,Waghodia, Dist Vadodara Gujrat-391760
Vadodara GUJARAT 391760 India |
| Phone |
9804822563 |
| Fax |
|
| Email |
imtiaz.dr2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital
P.O Limda,Tal Waghodia 391760 Vadodara, Gujarat |
|
|
Primary Sponsor
|
| Name |
Md Imtiaz Hossain |
| Address |
Parul Institute Of Ayurved, p.o Limda, Waghodia, Dist Vadodara, Gujrat |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Md Imtiaz Hossain |
Parul Institute Of Ayurved, p.o Limda, Waghodia, Dist Vadodara, Gujrat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Imtiaz Hossain |
Parul Institute of Ayurved and Hospital |
Panchakarma Dept,Parul Institute Of Ayurved, p.o Limda, Waghodia, Dist Vadodara, Gujrat Vadodara GUJARAT |
9804822563
imtiaz.dr2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jimutaka |
Drug: Jimutaka
Part used: fruit
Dosage: 12grms
Sahapan with Honey
As a vamak yoga
Duration 10 days |
| Intervention |
Madana Phala |
Drug-Madanaphala
Part used: pippali
Dosage: 12grms
Sahapan with Honey
As a vamak yoga
duration-10days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Patients indicated for Vamana.
Age group between 18-60 yrs of either gender.
Patient having the classical sign & symptoms of Ek-kushta.
Patients having Madhyam kostha
|
|
| ExclusionCriteria |
| Details |
Patients below 18 and above 60 years.
Psoriasis associated with other systemic
disorder.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in the symptoms of psoriasis |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relieve in the symptoms of psoriasis |
1 month |
|
|
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)
|
25/07/2019 |
| 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
|
not yet publishjed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The skin is the largest organ of the body. It is a link between internal and external environment. Being the seat of complexion it maintains beauty and personality. Any deformity or disease condition of this leads to both physiological and psychological disturbance of the patient. In Ayurveda all the skin diseases have been discussed under the “Kushtha†. In Ayurveda, Panchakarma plays an important role to eradicate the disease from its root, also to prevent Roga-utapatti. According to all Acharya’s Vaman karma is the principle Shodhan Chikitsa for Kapha disorders. Kushtha is consider as one the Ashta Mahagada by Brihatrayee which shows the prevalence of the disease. is one among Kshudra-Kushtha. The symptoms of Ek-kushta Ekakusth Aswedana, Mahavaastu( widely spreaded), Matsya shakalopamam( silvery scales).Due to the resemblance of signs and symptoms of Ekakushtha it can be correlated with Psoriasis. In Kushtha ‘Shodhana’ is the best line of management mentioned by all Acharya’s.Consumption of- junk food, fast food, cold drinks, smoking and drinking alcohol. Psoriasis is a skin disease which affects the 0.44 - 2.8% of the Indian population. Here Ayurveda plays an important role in Shodana chikitsa forms the mainstay of treatment for all major skin diseases in Ayurveda which helps to remove the deep seated Dosha’s from the root itself .Hence present clinical study will be undertaken to evaluate and compare the efficacy of Madanaphala yoga and Jeemutaka yoga in the management of Ekakushta as the analogue to psoriasis. These samples will be selected from IPD and OPD of Parul Ayurved Hospital and will be randomly allocated into two groups. Group1 with Jimukta Yoga and group2 with Madanaphala Yoga for Vamana Karma. After completion of the study statistical analysis will be done by using SPSS 23 and the result will be analysed |