| CTRI Number |
CTRI/2025/08/093086 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic Regimen for Garbhini Pandu |
|
Scientific Title of Study
|
Evaluation of the efficacy of Mandura Makshika Bhasma in the management of Garbhini Pandu w s r to Iron deficiency anaemia in pregnancy a Randomized controlled clinical trial |
| 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 Pragya Singh |
| Designation |
PG Scholar |
| Affiliation |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Room Number 23
Department of Streeroga and Prasuti Tantra
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya
Post graduate studies and research centre Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
8874848306 |
| Fax |
|
| Email |
pragya95552@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Bhagat |
| Designation |
Associate Professor |
| Affiliation |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Room Number 23
Department of Streeroga and Prasuti Tantra
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya
Post graduate studies and research centre Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
8123236686 |
| Fax |
|
| Email |
nayana.gavekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayana Bhagat |
| Designation |
Associate Professor |
| Affiliation |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Room Number 23
Department of Streeroga and Prasuti Tantra
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya
Post graduate studies and research centre Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
8123236686 |
| Fax |
|
| Email |
nayana.gavekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Pragya Singh |
| Address |
Pg Scholar
Department of Streeroga and Prasuti Tantra
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya
Post graduate studies and research centre Belagavi Karnataka India 590003 |
| Type of Sponsor |
Other [Self] |
|
|
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 Pragya Singh |
KLE Ayurveda Hospital Shahapur Belagavi |
Room Number 23
Department of Streeroga and Prasuti Tantra
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya
Post graduate studies and research centre Belagavi
Belgaum
KARNATAKA |
8874848306
pragya95552@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee for Reseach on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O280||Abnormal hematological finding onantenatal screening of mother, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ferrous Ascorbate |
Ferrous Ascorbate
Route of Administration Oral
Dose 100mg OD
Duration 45 Days |
| Intervention |
Mandura Makshika Bhasma |
Mandura Makshika Bhasma
Anupana Honey
Route of Administration Oral
Dose 125mg BD
Duration 45 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Confirmed diagnosis of Mild Iron Deficiency Anaemia 9 to 10 point 9 g per dl as per WHO criteria
Pregnant women in early second trimester between 14 weeks to 20 weeks 6 days
Age group 18 to 40 years
Singleton intrauterine pregnancy
Willingness to participate |
|
| ExclusionCriteria |
| Details |
Moderate to Severe Anaemia Moderate 7 to 8 point 9 g per dl Severe less than 7g per dl
Anaemia due to other causes such as megaloblastic anaemia thalassemia or sickle cell anaemia
Multiple pregnancy
Gestational age less than 14 weeks or more than 21 weeks
Chronic metabolic disorders hypertension diabetes hepatic and renal diseases GDM PIH Bleeding disorders like piles peptic ulcer oesophageal varices |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in hematological parameters and clinical
symptoms of Garbhini Pandu |
Baseline 22nd Day and 45th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2025 |
| 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
|
Anaemia affects 52 percentage of pregnant women in India
with Iron Deficiency Anaemia IDA responsible for about half of these cases
contributing significantly to maternal and perinatal complications
Conventional treatment involves oral iron supplements which
are effective but often poorly tolerated due to gastrointestinal side effects
leading to low adherence
Parenteral iron therapy is faster but expensive and risky
In Ayurveda although Garbhini Pandu isnt directly mentioned
related conditions like Vivarnata and Pandutwa are discussed
Traditional Ayurvedic medicines like Mandura Bhasma
and Swarna Makshika Bhasma have been used to manage anaemia
A unique formulation Mandura
Makshika Bhasma combines both
enhancing therapeutic effects especially for severe pitta related conditions
Despite the availability of modern formulations like ferrous
ascorbate side effects and poor bioavailability remain issues
Limited research exists on the combined effects of Mandura
and Swarna Makshika Bhasma This study aims to explore their synergy absorption
and potential as an effective Ayurvedic alternative for managing IDA in
pregnancy |