| CTRI Number |
CTRI/2020/02/023437 [Registered on: 19/02/2020] Trial Registered Prospectively |
| Last Modified On: |
12/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of daadim phala as increase blood level In Female With Low Hemoglobin Level. |
|
Scientific Title of Study
|
An Exploratory Clinical Trial To Evaluate Efficacy Of Daadimphala (Punica Granatum Linn.) As Raktavardhak
Aahar In Female Volunteers With Low Hemoglobin Level. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilesh Tanaji Shinde |
| Designation |
MD Final Year |
| Affiliation |
PDEAs college of ayurved and research centre |
| Address |
Ayurved Rugnalaya And Multispeciality Hospital Sector 27, Pradhikaran, Akuedi, Nigadi, Pune.
college of ayurved and research centre, department, akurdi, sector 25 ,nigadi, pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7709676780 |
| Fax |
|
| Email |
nileshinde123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajkumar B Bobade |
| Designation |
HOD, department of swasthavrutta |
| Affiliation |
PDEAs college of ayurved and research centre |
| Address |
college of ayurved and research centre, department, first floor, akurdi, sector 25 ,nigadi, pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9403928005 |
| Fax |
|
| Email |
rajkumarbobade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilesh Tanaji Shinde |
| Designation |
MD Final Year |
| Affiliation |
PDEAs college of ayurved and research centre |
| Address |
Ayurved Rugnalaya And Multispeciality Hospital Sector 27, Pradhikaran, Akuedi, Nigadi, Pune.
college of ayurved and research centre, department, akurdi, sector 25 ,nigadi, pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7709676780 |
| Fax |
|
| Email |
nileshinde123@gmail.com |
|
|
Source of Monetary or Material Support
|
| college of ayurved and research centre, nigadi, pune 411044 |
|
|
Primary Sponsor
|
| Name |
college of ayurved and research centre |
| Address |
pradhikaran,sector25,nigadi, pune411044 |
| 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 |
| DrRajkumar BBobade |
PDEAs college of Ayurved And Research Centre |
Swasthyarakshan department 1st floor pradhikaran sector no.25,Nigadi,Pune 411044
Pune
MAHARASHTRA |
9403928005
rajkumarbobade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
female volunteers with low hemoglobin level i.e above 9gm/dl and bellow 12gm/dl age group between 14 yrs to 25 yrs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dadim phala |
100gm/day for 45 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
female volunteers with low hemoglobin level i.e below 12gm/dl and above 9gm/dl |
|
| ExclusionCriteria |
| Details |
1.patient on hematinic treatment.
2.pregnant and lactating women.
3.secondary anemia.
4.any major and chronic disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| raktavardhan property of dadim phala i.e hamoglobin level will be assesed. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| raktavardhan property of dadim phala i.e hamoglobin level will be assesed. |
15 and 30th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/02/2020 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The prevalence of anemia is slightly higher in younger women less than 25 years of age than in older women. It is considerably higher for rural women(54%) than in urban women (46%) and so looking towards its prevalence, it is included in national health program of India.As Daadimphala is aahariyadravya and easily available in market with cost effective, the Daadimphala(Punicagranatum Linn.) can be recommended as dietary supplement for raktavardhan, so topic has been selected to study. |