| CTRI Number |
CTRI/2020/09/028031 [Registered on: 24/09/2020] Trial Registered Prospectively |
| Last Modified On: |
23/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Anaemia |
|
Scientific Title of Study
|
An etiopathological study of Pandu Roga w.s.r.to Iron deficiency anaemia along with evaluation of therapeutic effect (upshayatmak parikshana) of Vibheetakadi Vatak by estimation of Hb percentage |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONU SINGH |
| Designation |
MD SCHOLAR |
| Affiliation |
Govt Ayurveda PG College And Hospital Varanasi |
| Address |
OPD NO 10 Govt PG Ayurveda College Varanasi
Department of Roga Nidan Govt PG Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8887617452 |
| Fax |
|
| Email |
drsonurac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHAILENDRA KUMAR SINGH |
| Designation |
Lecturer |
| Affiliation |
Govt PG Ayurveda College and hospital Varanasi Uttar Pradesh |
| Address |
Dept of Rog Nidan Govt PG Ayurveda College and hospital Varanasi
OPD no 10 department of Rog Nidan Govt PG Ayurveda College and hospital Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9453360096 |
| Fax |
|
| Email |
singhshailendra1001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHAILENDRA KUMAR SINGH |
| Designation |
Lecturer |
| Affiliation |
Govt PG Ayurveda College and hospital Varanasi Uttar Pradesh |
| Address |
Dept of Rog Nidan Govt PG Ayurveda College and hospital Varanasi
OPD no 10 department of Rog Nidan Govt PG Ayurveda College and hospital Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9453360096 |
| Fax |
|
| Email |
singhshailendra1001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt PG Ayurveda College and Hospital Sampurnanand Sanskrit University Varanasi |
|
|
Primary Sponsor
|
| Name |
Govt PG Ayurveda College and Hospital Chaukaghat Varanasi |
| Address |
Govt PG Ayurveda College and Hospital Chaukaghat Varanasi |
| 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 |
| Sonu Singh |
Govt PG Ayurvedic College and Hospital, |
PG department of Rog Nidan
Prashashanik bhawan
Government PG Ayurveda College and hospital Varanasi
Varanasi
UTTAR PRADESH |
8887617452
drsonurac@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50||Iron deficiency anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Vibheetakadi Vatak |
TOTAL 40 PATIENTS OF PANDU ROGA WILL BE GIVEN 2 VATAK BD FOR 30 DAYS |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Iron efficiency Anaemia
Patient between age group 10 to 50 yrs of both sex
Blood sample having Hb% 6 gm % to 11 gm % |
|
| ExclusionCriteria |
| Details |
Patient below 10 years and above 50 years
Blood sample having Hb % less than 6 gm %
Any heamorrhagic disorders/ heriditory condition
Patient suffering from any chronic disease like kidney disease, leukaemia,D.M,T.B etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in sign and symptoms of Pandu Roga with increasing Hb% |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve quality of life of patients |
after 45 days from day of enrollment |
|
|
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 2 |
|
Date of First Enrollment (India)
|
30/09/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Under this clinical study minimum 40 patients of Pandu Roga will be treated with Vibheetakadi Vatak . Patient’s selection will be based on Laboratory Hb% estimation . The constituent of Vibheetakadi Vatak are Vibheetak churna , Mandur bhasma , krishna til and Shunthi churna . Properties of these drugs are Rakta stambhan , Rakta Shodhan, Rakta Vardhan . The period of trial will be 30 days with 7days follow up . Patient will be selected from the O.P.D. and I.P.D. and will be Diagnosed on the basis of sign and symptoms and Hb % ,then assessment will be done and conclusion will be drawn after completion of study . |