| CTRI Number |
CTRI/2024/09/074004 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
ASSESING OJA KSHAYA IN PANDU ROGA WITH Hb gm percent |
|
Scientific Title of Study
|
ASSESMENT OF OJA-KSHAYA IN PANDU ROGA W.S.R. TO Hb gm percent |
| 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 Jasmeet Kaur Dhillon |
| Designation |
PG scholar |
| Affiliation |
Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
| Address |
OPD no.21 of Rog nidan evum vikriti vigyan department, Rishikul campus, UAU, Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8191081780 |
| Fax |
|
| Email |
jasmeetd07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruby Rani Agarwal |
| Designation |
Professor |
| Affiliation |
Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
| Address |
OPD no.21 of Rog nidan evum vikriti vigyan department, Rishikul campus, UAU, Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9997061369 |
| Fax |
|
| Email |
ruby6758@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruby Rani Agarwal |
| Designation |
Professor |
| Affiliation |
Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
| Address |
OPD no.21 of Rog nidan evum vikriti vigyan department, Rishikul campus, UAU, Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9997061369 |
| Fax |
|
| Email |
ruby6758@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, UAU, Haridwar pin-249401 |
|
|
Primary Sponsor
|
| Name |
Rishikul campus UAU |
| Address |
Rishikul campus,UAU,Haridwar, Uttarakhand, INDIA, pincode-249401 |
| 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 Jasmeet Kaur Dhillon |
Rishikul campus, UAU,Haridwar |
OPD no.21 of Rog nidan evum vikriti vigyan department, Rishikul campus, UAU, Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL |
8191081780
jasmeetd07@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:D539||Nutritional 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 16 yrs to 60yrs.
Patient having Hb gm% value lower than 11 gm/dl.
|
|
| ExclusionCriteria |
| Details |
Patients below 16 years and above 60 years of age.
Patients having pre diagnosed case of blood dyscrasia and hemoglobinopathies
e.g.:- Thalassemia, sickle cell anaemia.
Known cases of HIV, Tuberculosis, malignant diseases, cases of acute blood loss, etc.
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Oja-kshaya on the basis of Haemoglobin concentration. |
01 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess status of Oja-kshaya on the basis of severity of symptoms of Pandu. |
01 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
23/09/2024 |
| 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 will be done to assess Oja Kshaya in Pandu Roga w.s.r. to haemoglobin(gm%). Patients having Hb gm% value lower than 11 gm/dl will be taken in this study. Classical symptoms of Pandu Roga and Oja Kshaya will be assesed in these patients. A relation between severity of Pandu and Haemoglobin concentration with Oja- kshaya will be established. This study will pave a new avenue for treatment and prevention of Pandu focusing on quality of Oja.
|