| CTRI Number |
CTRI/2019/04/018734 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
16/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
"A study to observe the symptoms of Pandu roga in beta thalassemia patients with reference to Hb- electrophoresis". |
|
Scientific Title of Study
|
"An observational study to assess the lakshana of Pandu vyadhi in beta thalassemia patients with special reference to Hb-electrophoresis". |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Naresh Shukla |
| Designation |
PG second year |
| Affiliation |
PDEAS college of ayurved and research centre ,nigdi |
| Address |
Ayurved rugnalaya and sterling multi-speciality hospital Pathology lab room no 115 sector no 27 pradhikaran nigdi Pune 411044
Pune Maharashtra
411044
India
PDEAS college of ayurved and research centre Rognidan department 1st floor nigdi pradhikaran Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7038797228 |
| Fax |
|
| Email |
sweetrohit.shukla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Singh |
| Designation |
Associate professor rognidan department |
| Affiliation |
PDEAS college of ayurved and research centre nigdi |
| Address |
Ayurved rugnalaya and sterling Multi-speciality hospital pathology lab room no 115 sector no 27 pradhikaran nigdi Pune 411044
PDEAS college of ayurved and research centre Rognidan department 1st floor nigdi pradhikaran pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9890741683 |
| Fax |
|
| Email |
drsatyendra@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Naresh Shukla |
| Designation |
PG second year |
| Affiliation |
PDEAS college of ayurved and research centre nigdi |
| Address |
Ayurved rugnalaya and sterling multi-speciality hospital pathology lab room no 115 sector no 27 pradhikaran nigdi Pune
PDEAS college of ayurved and research centre Rognidan department 1st floor nigdi pradhikaran Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7038797228 |
| Fax |
|
| Email |
sweetrohit.shukla@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS college of ayurved and research centre nigdi pradhikaran sector no 25 Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS college of ayurved and research centre nigdi |
| Address |
Sector no 25 pradhikaran nigdi Pune 411044 |
| Type of Sponsor |
Private 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 Rohit Naresh Shukla |
Ayurved rugnalaya and sterling multi-speciality hospital |
Pathology lab room no 115 Sector no 27 pradhikaran nigdi Pune
Pune
MAHARASHTRA |
7038797228
sweetrohit.shukla@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: D759||Disease of blood and blood-formingorgans, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
K/c/o beta thalassemia patients will be preferred on the basis of Hb-electrophoresis for present study |
|
| ExclusionCriteria |
| Details |
k/c/o HIV,HBV infection,hepatic failure or such major illness will be excluded.pregnant women
Patient having haemorrhagic disorder.
Surgical intervention like splenectomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Descriptive study |
Samanya lakshana of Pandu vyadhi will be observed in beta thalassemia patients in single time. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Descriptive study |
Doshaj lakshana of Pandu vyadhi will be observed in beta thalassemia patients in single time. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
26/04/2019 |
| 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="10" |
|
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
|
Corelation of symptoms of Pandu vyadhi with thalassemia patients can help in early detection of disease and hence help in proper management of disease through ayurved perspective.if one can diagnose the disease on the basis of this corelation the treatment of the disease can be started soon and life of patients can be prolonged or save and hence the topic is selected. |