| CTRI Number |
CTRI/2019/12/022413 [Registered on: 18/12/2019] Trial Registered Prospectively |
| Last Modified On: |
11/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Psoriasis through Ayurveda |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF SIDHARTAK LEPA VAMANA & VIRECHAN IN THE MANAGEMENT OF EKAKUSTHA W.S.R. TO PSORIASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Richa Parmar |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G. Department of Panchakarma, Dr. Sarvepalli radhakrishnan Rajasthan Ayurved University, Karwar, Nagaur Road, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8290275758 |
| Fax |
|
| Email |
parmaricha90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Kumar Sharma |
| Designation |
Associate Professor & HOD |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G. Department of Panchakarma, Dr. Sarvepalli radhakrishnan Rajasthan Ayurved University, Karwar, Nagaur Road, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829695452 |
| Fax |
|
| Email |
drmksharma2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Parmar |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G. Department of Panchakarma, Dr. Sarvepalli radhakrishnan Rajasthan Ayurved University, Karwar, Nagaur Road, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8290275758 |
| Fax |
|
| Email |
parmaricha90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sarvepalli Radhakrishnan rajasthan Ayurved University, Karwar, Nagaur Road, Jodhpur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Nagaur Road Jodhpur |
| Type of Sponsor |
Government 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 Mahesh Kumar Sharma |
Dr. Sarvepalli Radhakrishnan rajasthan Ayurved University, University Hospital of Ayurved |
OPD No. - 6 P.G. Department of Panchakarma Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Nagaur Road,Jodhpur
Jodhpur
RAJASTHAN |
9829695452
drmksharma2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Commitee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sidharthak Lepa |
Sidharthak Lepa as external medicine for 30 days |
| Intervention |
Vamana Karma |
Vamana Karma by Sidhartak Churna as Shodhana karma for 30 Days |
| Comparator Agent |
Vamana, Vitrechana & Sidharthak Lepa |
Vamana Karma & Virechana Karma by Sidharthak Churna and Sidharthak Lepa as external medicine for 30 days |
| Comparator Agent |
virechana Karma |
Virechana karma by Sidharthak Churna as Shodhana karma for 30 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed and confirmed cases of Ekakustha (Psoriasis) on the basis of sign and symptoms.
2. Patients between the age group of 18 to 60 years of either sex. |
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years and above 60 years.
2. Infective origin.
3. Allergic disease
4. Immuno compromised like HIV, HBV.
5. Malignancy or patient going through treatment.
6. Pregnant and lactating women.
7. Clinically unfit for Shodhana.
8. Patient having cardiac disease, renal disease and endocrine disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the subjective and objective Parameters |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the comparative efficacy of the Vamana karma, Virechana karma and Lepana |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
20/12/2019 |
| 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="0"
Months="6"
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)?
|
|
Brief Summary
|
Psoriasis is one of the top listed dermatological problem of present era. Ayurvedic medicines and panchakarma procedures are Highly effective in the treatment of psoriasis because of their raktashodhak, Vata-kapha shamak, Rasayana properties. This study is a open label parellal group clinical trial to treat the Ekakustha (Psoriasis). In one group Vamana Karma will be done by Sidharthak Churna for 30 days in 10 patients. In 2nd group Virechana Karma will be done by Sidharthak Churna for 30 days in 10 patients. In 3rd group Sidharthak Lepa will be used as external medicine for 30 days in 10 patients. in 4th group Vamana and Virechana karma will be done by Sidharthak Churna along with external application of Sidharthak Churna for 30 days in 10 patients. |