| CTRI Number |
CTRI/2021/02/030976 [Registered on: 03/02/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Anemia Project Pandu Roga Public Health Initiative Scheme |
|
Scientific Title of Study
|
Management of Pandu (anemia) in adolescent girls and women of reproductive age group with Ayurvedic medicines in Jamnagar Taluka of Jamnagar district |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Pashmina Joshi |
| Designation |
Reader |
| Affiliation |
Shri Gulabkunverba Ayurved Mahavidyalaya |
| Address |
Shalya Tantra Dept
Shri Gulabkunverba Ayurved Mahavidyalaya
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427226504 |
| Fax |
|
| Email |
kalpashmina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Pashmina Joshi |
| Designation |
Reader |
| Affiliation |
Shri Gulabkunverba Ayurved Mahavidyalaya |
| Address |
Shalya Tantra Dept
Shri Gulabkunverba Ayurved Mahavidyalaya
Gujarat Ayurved University
Jamnagar
GUJARAT
361008
India |
| Phone |
9427226504 |
| Fax |
|
| Email |
kalpashmina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Pashmina Joshi |
| Designation |
Reader |
| Affiliation |
Shri Gulabkunverba Ayurved Mahavidyalaya |
| Address |
Shalya Tantra Dept
Shri Gulabkunverba Ayurved Mahavidyalaya
Gujarat Ayurved University
Jamnagar
GUJARAT
361008
India |
| Phone |
9427226504 |
| Fax |
|
| Email |
kalpashmina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ministy of AYUSH
AYUSH Bhawan
B block GPO complex
INA New Delhi 110023 |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
AYUSH Bhawan
B block GPO complex
INA New Delhi 110023 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Vd Pashmina Joshi |
Shri Gulabkunverba Ayurved Mahavidyalaya Gujarat Ayurved University |
Room No 29 Shalya Tantra Dept Shri Gulabkunverba Ayurved Mahavidyalaya Dhanvantari Mandir
Gujarat ayurved university
Jamnagar Gujarat
Jamnagar
GUJARAT |
9427226504
kalpashmina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drakshavaleha and Punarnavadi Mandur |
Drakshavaleha 20g for 90 days twice a day
Punarnavadi Mandur 3g for 90 days twice a day |
| Comparator Agent |
Elemental Iron and Folic Acid |
100 mg Elemental Iron and
500 mcg Folic Acid |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Adolescent girls and women reproductive age group diagnosed as Pandu with 6 to 10 gm % of Hb or reduced RBC count |
|
| ExclusionCriteria |
| Details |
Age less than 12 years and more than 50 years
Pregnancy and Lactation
Severe Renal (CRF) hepatic cardiac diseases (CCF) Cancer any continuing blood loss eg Hematemesis melena menorraghic etc
patients of any haematinic drug (Ayurveda or Modern) within last one month |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishment of Ayurved Therapy for treating anemia for large population of female subjects Diet and Lifestyle modification according to Ayurveda Yoga and Naturopathy for 2400 subjects undergoing clinical trail |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Screening will be 11000 and spreading awareness regarding anemia diet and life style modification for its prevention |
16 weeks |
|
|
Target Sample Size
|
Total Sample Size="2400"
Sample Size from India="2400"
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)
|
15/02/2021 |
| 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="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This Project Mainly focus to address the prevalent anemia among the adolescent girls and reproductive age group women and other Health care needs of Physical , mental and counselling.Total 92
medical camps have been conducted at various centres in Jamnagar Taluka since
the commencement of the trial for screening of anaemic patients/beneficiaries
for the current trial. The total screening number till date is 10,501.
In group
A (Trial drug), total 1273 beneficiaries were enrolled, out of which 919
beneficiaries have completed the course of drug, 169 beneficiaries discontinued
the course (LAMA), 8 were excluded from the study considering the exclusion
criteria.(161 beneficiaries discontinued the course due to COVID19 lockdown).
In group
B ( Control group ), total 392 beneficiaries were enrolled, out of which 185 beneficiaries
have completed the course of drug, 82 beneficiaries discontinued the course
(LAMA), 8 were excluded from the study considering the exclusion criteria.(33
beneficiaries discontinued the due to COVID19 lockdown). Currently, 121 beneficiaries
are under study period.
|