| CTRI Number |
CTRI/2024/10/075035 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of causes of Pandu and its comparison with Red cell indices |
|
Scientific Title of Study
|
Etiopathological Study Of Pandu W.S.R to Red Cell Indices |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Princi Verma |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University,Rishikul Campus ,Haridwar |
| Address |
OPD and IPD No.21 of Rog Nidan evum vikriti vigyan department ,Rishikul campus,UAU,Haridwar,Uttarakhand,249401,India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7983020929 |
| Fax |
|
| Email |
princiverma1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Singh |
| Designation |
Associate professor |
| Affiliation |
Uttarakhand Ayurved University,Rishikul Campus ,Haridwar |
| Address |
OPD and IPD No. 21 of Rog Nidan evum vikriti vigyan department,Rishikul campus,UAU,Haridwar,Uttarakhand,249401,India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9415284453 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Princi Verma |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University,Rishikul Campus ,Haridwar |
| Address |
OPD and IPD No. 21 of Rog nidan evum vikriti vigyan department,Rishikul Campus,UAU,Haridwar,Uttarakhand ,Pin code-249401,India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7983020929 |
| Fax |
|
| Email |
princiverma1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus,Uttarakhand Ayurved University,Haridwar,pin code-249401 |
|
|
Primary Sponsor
|
| Name |
Rishikul CampusUAU |
| Address |
Rishikul Campus,UAU,Haridwar,pin code-249401,India |
| 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 Princi Verma |
Rishikul Campus, Haridwar |
OPD and IPD NO.21,Rog nidan evum vikriti vigyan department,Rishikul Campus,UAU,Haridwar,Uttaranchala
Hardwar
UTTARANCHAL |
7983020929
princiverma1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee,Uttarakhand Ayurved University,Rishikul Campus,Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age group of 16-60 years of either sex fulfilling diagnostic criteria for Pandu will be included in the study |
|
| ExclusionCriteria |
| Details |
below 16 years and above 60 years
Known case of AIDS,Cancer,Tuberculosis,Thyroid disorders,Chronic Renal Failure,DM and other complicated systemic disorders and any psychaitric illness
Pregnant and lactating women
Anaemia associated with bone marrow depression,Thalassemia,Leukemia
Hb less than 6g/dl |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the etiopathology of Pandu |
01 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the severity of Pandu in the relation to Red Cell Indices |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is done for studying etiological factors of Pandu . And for finding out any relationship between severity of general symptoms of Pandu and Red Cell Indices. Patients will be taken according to the Hb level and considering the classical features of Pandu and after observing the etiological factors and symptoms of patients , the values of Red Cell Indices of the patient will be compared to the severity of symptoms .
|