| CTRI Number |
CTRI/2015/09/006200 [Registered on: 18/09/2015] Trial Registered Retrospectively |
| Last Modified On: |
18/01/2016 |
| 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
|
A Clinical trial to study the effect of two drugs Pathyaa ghrita and vidangadi lauha in patient with Pandu |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF VIDANGADI LAUHA AND PATHYAA GHRITA (SHAMANA SNEHA) IN THE MANAGEMENT OF PANDU ROGA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MISS VAISHALI N SAVAJ |
| Designation |
M.D. (Ayu) SCHOLAR |
| Affiliation |
GOVT AKHANDANAND AYURVED COLLEGE, AHMEDABAD |
| Address |
191/LAXMI NAGAR SOC.
NEAR SARTHANA JAKATNAKA
SARTHANA
SURAT 395006
GOVT AKHANDANAND AYURVED COLLAGE,BHADRA AHMEDABAD 380001
Ahmadabad
GUJARAT
395006
India |
| Phone |
09727185469 |
| Fax |
|
| Email |
vaishu.savaj1105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAshok Pandya |
| Designation |
MD (ayu.) Kayachikitsa |
| Affiliation |
GOVT AKHANDANAND AYURVED COLLEGE, AHMEDABAD |
| Address |
Government akhandanad Ayurved collage,Bhadra,Ahmedabad.
GOVT AKHANDANAND AYURVED COLLAGE,BHADRA AHMEDABAD 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
9879090959 |
| Fax |
|
| Email |
ashokpandya01@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MISS VAISHALI N SAVAJ |
| Designation |
M.D. (Ayu) SCHOLAR |
| Affiliation |
GOVT AKHANDANAND AYURVED COLLEGE, AHMEDABAD |
| Address |
191/LAXMI NAGAR SOC.
NEAR SARTHANA JAKATNAKA
SARTHANA
SURAT 395006
GOVT AKHANDANAND AYURVED COLLAGE,BHADRA AHMEDABAD 380001
GUJARAT
395006
India |
| Phone |
09727185469 |
| Fax |
|
| Email |
vaishu.savaj1105@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT AKHANDANAND AYURVED COLLAGE,AHMEDABAD AND MANIBEN AYURVED HOSPITAL,AHMEDABAD |
|
|
Primary Sponsor
|
| Name |
GOVT AKHANDANAND AYURVED COLLEGE |
| Address |
GOVT AKHANDANAND AYURVED COLLEGE,BHDRA,AHMEDABAD |
| 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 |
| MISS VAISHALI N SAVAJ |
GOVT AKHANDANAND AYURVED COLLEGE AHMEDABAD AND MANIBEN AYURVED HOSPITAL AHMEDABAD |
BHADRA, AHMEDABAD 380001
Ahmadabad
GUJARAT |
09727185469
vaishu.savaj1105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE, GOVT AKHANDANAND AYURVED COLLEGE, AHMEDABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PANDU ROGA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A-PATHYAA GHRITA AND VIDANGADI LAUHA |
PATHYAA GHRITA-15 ml OD FOR 1 MONTH AND 15 DAYS
VIDANGADI LAUHA- 4 TABLETS (EACH 250 mg) BD FOR 1 MONTH AND 15 DAYS |
| Comparator Agent |
GROUP B- VIDANGADI LAUHA |
4 TABLETS (EACH 250 mg) BD FOR 1 MONTH AND 15 DAYS |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
THE PATIENTS WILL BE SELECTED ON THE BASIS OF SIGN AND SYMPTOM OF PANDU ROGA DISCRIBED IN AYURVED CLASSIC, PATIENTS HAVING Hb- 6gm% TO 10gm% |
|
| ExclusionCriteria |
| Details |
CONGENITAL ANEMIA LIKE THALASSEMIA, SICKEL CELL ANEMIA, LEUKEMIA, APLASTIC ANEMIA, ANEMIA DUE TO BLEEDING PILES, MENORRHAGIA
MAJOR DISEASE LIKE CARDIC DISEASE, D.M. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BY OBSERVING CLINICAL IMPROVEMENT IN SIGN AND SYMPTOM OF PANDU ROGA AND LABORATERY INVESTIGATIONS BEFORE AND AFTER TREATMENT |
1 MONTH AND 15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS STUDY IS A RANDOMISED, PARTICIPENT BLINDED, PRALLEL GROUP, ACTIVE CONTROLLED TRIAL TO COMPARE THE EFFICACY OF PATHYAA GHRITA IN DOSE OF 15 ml IN MORNING ANNAPRAKANKSHE KALE WITH VEHICAL OF USHNODAKA AND VIDANGADI LAUHA 4 TABLETS (250 mg EACH) BD WITH VEHICAL OF WATER FOR THE DURATION OF 1 MONTH AND 15 DAYS IN 17 PATIENTS OF PANDU ROGA AND VIDANGADI LAUHA 4 TABLETS (250 mg EACH) BD WITH VEHICAL OF WATER FOR THE DURATION OF 1 MONTH AND 15 DAYS IN 17 PATIENTS OF PANDU ROGA WILL BE CONDUCTED IN INDIA |