| CTRI Number |
CTRI/2013/12/004213 [Registered on: 13/12/2013] Trial Registered Prospectively |
| Last Modified On: |
12/12/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ROLE OF GUDUCHI(PROCESSED) ON EKA KUSTHA (PSORIASIS) |
|
Scientific Title of Study
|
EFFECT OF GUDUCHI CHURNA KRIYA PREPARED WITH GUDUCHI SWARASA DERIVED BY TWO DIFFERENT METHODS ON EKA KUSTHA (PSORIASIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANDEEP |
| Designation |
MD SCHOLAR |
| Affiliation |
IPGT AND RA |
| Address |
Room no 61 PG Boys Hostel Institute for Post Graduate Teaching and Research in Ayurveda GAU
Jamnagar
GUJARAT
361008
India |
| Phone |
9998823095 |
| Fax |
|
| Email |
drsandeep.ayu88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Bedarkar |
| Designation |
Assistant Professor |
| Affiliation |
IPGT AND RA |
| Address |
Dept of RS and BK
Institute for Post Graduate Teaching and Research in Ayurveda GAU
Jamnagar
GUJARAT
361008
India |
| Phone |
8128217370 |
| Fax |
02882676856 |
| Email |
drprashantbedarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Bedarkar |
| Designation |
Assistant Professor |
| Affiliation |
IPGT AND RA |
| Address |
Dept of RS and BK
Institute for Post Graduate Teaching and Research in Ayurveda GAU
Jamnagar
GUJARAT
361008
India |
| Phone |
8128217370 |
| Fax |
02882676856 |
| Email |
drprashantbedarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Institute for Post Graduate Teaching and Research in Ayurveda jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda jamnagar 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SANDEEP AGRAWAL |
Institute for Post Graduate Training and Research in Ayurved |
Department of RS and BK Institute for Post Graduate Training and Research in Ayurved GAU
Jamnagar
GUJARAT |
9998823095
drsandeep.ayu88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Institute for Post Graduate Training and Research in Ayurved GAU Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having signs and symptoms of EKA KUSTHA (Psoriasis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A: SBGC1- with less duration of immersion |
dosage: 6 gm per day in divided doses before meal.
For local Application: Tila Taila Qs
Duration :8 weeks |
| Comparator Agent |
Group B :SBGC2- with more duration of immersion |
dosage: 6 gm per day in divided doses before meal.
For local Application: Tila Taila Qs
Duration :8 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Patients having classical sign and symptoms of Eka Kustha
•Age group of patients will be between 16-60 years. |
|
| ExclusionCriteria |
| Details |
•Life threatening medical and surgical emergencies.
•Age below 16 and above 60 years
•Known case of D.M with uncontrolled blood sugar level, AIDS, Malignancy, Immuno-compromised state etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Improvement in the signs and symptoms of the disease as per Ayurvedic texts.
•The obtained data will be statistically analyzed and presented along with explanatory notes, discussion and conclusion.
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement will be assessed on the basis of relief found in cardinal symptoms of disease Progress in the signs and symptoms based on the standard pattern will be applied before and after treatment. |
30 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)
|
20/12/2013 |
| 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="2"
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)?
|
|
Brief Summary
|
The present study is designed with the aim to evaluate the efficacy of Swarasa bhavita Guduchi Churna (powder of Guduchi levigated with its juice) derived by more duration of immersion (12 hrs) is more effective as compared to the sample derived by less duration of immersion (extracted immediately).
Study will be double blind, randomized trial. Selected patients will be studied under following groups: | Grouping | Drug Formulation | Dosage (powder) | For local Application | Duration | | Group A | SBGC1- with less duration of immersion | 6 gm per day in divided doses before meal. | Tila Taila Qs | 8 weeks | | Group B | SBGC2- with more duration of immersion | 6 gm per day in divided doses before meal. | Tila Taila Qs | 8 weeks | Follow up: Patients will be reviewed after each 7 day for a period of 4 weeks. |