| CTRI Number |
CTRI/2021/09/036872 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
25/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Panchakarma procedures and Ayurvedic medicines in the management of Vicharchika (Eczema). |
|
Scientific Title of Study
|
Comparative study of Virechana and Shamana Chikitsa in Vicharchika W.S.R to Eczema. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Sood |
| Designation |
Principal Cum Professor & Head Department of Panchakarma |
| Affiliation |
Dayanand Ayurvedic College Jalandhar, Punjab |
| Address |
Department of Panchakarma, Dayanand Ayurvedic College,Mahatama Hans Raj Marg, G.T Road Jalandhar Punjab
Jalandhar
PUNJAB
144008
India |
| Phone |
9814004142 |
| Fax |
|
| Email |
drsanjeevsood@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chander Shekhar Sharma |
| Designation |
Professor & Head Department of Kayachikitsa |
| Affiliation |
Dayanand Ayurvedic College Jalandhar, Punjab |
| Address |
Department of Panchakarma, Dayanand Ayurvedic College,Mahatama Hans Raj Marg, G.T Road Jalandhar Punjab
Jalandhar
PUNJAB
144008
India |
| Phone |
9417785499 |
| Fax |
|
| Email |
shekhars76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha |
| Designation |
M.D Student (Panchakarma) |
| Affiliation |
Dayanand Ayurvedic College Jalandhar, Punjab |
| Address |
Panchakarma Department,Dayanand Ayurvedic College,Mahatama Hans Raj Marg, G.T Road Jalandhar Punjab
Jalandhar
PUNJAB
144008
India |
| Phone |
7986563993 |
| Fax |
|
| Email |
nehachd111.ns@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College, Mahatama Hans Raj Marg, G.T Road Jalandhar Punjab-144008 |
|
|
Primary Sponsor
|
| Name |
Dr Neha |
| Address |
Panchakarma Department,Dayanand Ayurvedic College,Mahatama Hans Raj Marg, G.T Road Jalandhar Punjab |
| Type of Sponsor |
Other [[Self ( Dr Neha MD Scholar)]] |
|
|
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 Chander Shekhar Sharma |
Dayanand Ayurvedic College Jalandhar |
Department of Panchakarma, Dayanand Ayurvedic College,Mahatama Hans Raj Marg, G.T Road Jalandhar Punjab
Jalandhar
PUNJAB |
9417785499
shekhars76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAC INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: Vicharchika (Eczema), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Virechana karma,
Shamana treatment(Eladi Lepa, Navakashaya) |
In this comparative study deepan-pachana with Panchakola powder 3gms three times a day for 3 days will be given then snehapana with Panchatikta ghee will be given in increasing order till desired lakshan attained after that 3 days rest will be given and during 3 days period Massage full body with murchita tila oil followed by bashpa swedana will be performed then on this above 3rd day Virechana with Danti (Baliospermum montanum) and Trivrit(Operculina turpethum) powder 3gms each along with 100ml Triphala decoction will be given orally in the morning empty stomach and from the evening of virechana karma samsarjana(Diet regime) will be followed according to Shudhi and light diet will be given
After this in group-A patients Eladi lepa will be locally applied twice a day for 30 days and in group-B patients Navakashaya will be given orally 20ml twice a day after meal for 30 days and evaluate or compare the efficacy between both groups |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for trial, diagnosed Eczema on the basis of signs & symptoms and fit for Virechana and Shamana treatment. |
|
| ExclusionCriteria |
| Details |
Patients less than 20 years & more than 60years,infected patch and pus collection, secondary infection, chronic diseases, malignancy, pregnant, lactating women and unfit patients for Virechana & Shamana treatment. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessed by change in the signs and symptoms of vicharchika |
50 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessed by change in the objective parameters |
50 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
29/09/2021 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Eczema patients will be selected according to signs and symptoms i.e 50 patients will be selected and divided into two groups each consists of 25 patients and conduct a clinical study to find whether is there any difference between Virechana procedure followed by Eladi lepa and followed by Navakashaya in the management of Vicharchika w.s.r to Eczema and evaluate the efficacy of virechana followed by Eladi lepa and followed by Navakashaya and compare the efficacy and safety of both. |