| CTRI Number |
CTRI/2024/08/072535 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| 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
|
To Study the effect of Loha Gudhadi Gutika in Garbhini Pandu w.s.r to Iron Deficiency Anemia in Pregnancy |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the effect of Loha Gudhadi Gutika in the management of Garbhini Pandu w.s.r to Iron Deficiency Anemia in Pregnancy |
| 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 Deepa C S |
| Designation |
Post Graduate Resident in Prasuti Tantra Evum Stree Roga |
| Affiliation |
Dr.N A Magadum Ayurvedic Medical College ,Hospital and Research Center |
| Address |
Room No-1,Department of Prasuti tantra evum stree roga,Dr.N.A.Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213,Chikodi Taluk.
Taluk-chikodi, Dist- Belgaum
Belgaum
KARNATAKA
591213
India |
| Phone |
8951986342 |
| Fax |
|
| Email |
deepacscs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mrs .Vandana S Kulkarni |
| Designation |
Professor and HOD Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Dr.N.A.Magadum Ayurvedic Medical College,Hospital and Research Center, Ankali-591213 |
| Address |
Room No-1,Department of Prasuti Tantra Evum Stree Roga,Dr.N.A.Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213,
Taluk-chikodi, Dist- Belgaum
Belgaum
KARNATAKA
591213
India |
| Phone |
9480017899 |
| Fax |
|
| Email |
drvandanaskulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mrs. Vandana S Kulkarni |
| Designation |
Professor and HOD Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Dr.N.A.Magadum Ayurvedic Medical College Hospital and Research Center, Ankali-591213 |
| Address |
Room No-1,Department of Prasuti Tantra Evum Stree Roga,Dr.N.A.Magadum Ayurvedic Medical College, Hospital and Research Center, Ankali 591213,
Taluk-chikodi, Dist- Belgaum
Belgaum
KARNATAKA
591213
India |
| Phone |
9480017899 |
| Fax |
|
| Email |
drvandanaskulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.N A Magadum Ayurvedic Medical College,Hospital and Research Centre Ankali 591213,Chikodi Taluk,Belagavi District,Karnataka State,India country. |
|
|
Primary Sponsor
|
| Name |
DrDeepa CS |
| Address |
Dr.N.A.Magadum Ayurvedic Medical College,Hospital and Research Center,Ankali-591213
Taluk-Chikodi,Dist-Belgaum.
|
| Type of Sponsor |
Other [others(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 Deepa CS |
Dr.N.A. Magadum Ayurvedic Medical College Hospital and Research Center |
Room No-1,Department of Prasuti Tantra Evum Stree Roga,Ankali-591213.
Taluk-Chikodi,Dist-Belgaum.
Belgaum
KARNATAKA |
8951986342
deepacscs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.N A Magadum Ayurvedic Medical College,Hospital and Research centre Ankali-591213,Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Loha Gudhadi Gutika, Reference: Sahasrayogam,Dr.Ram Nivas Sharma,Chapter no-9,13th formulation,page no-227, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab.Orofer XT | Ferrous Ascorbate equivalent to elemental Iron 100mg,Folic acid 1.5mg,with water,in Dose of 1 tablet orally,once a day,After food,for 60 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
pregnant women between age 18years to 30 years ,whose Hb percentage is between 7gm% to 10gm%,with Microcytic hypochromic anemia on peripheral blood smear(iron deficiency anemia)
both primi and multigravida Womens
pregnancy between 16 weeks to 24 weeks of gestational age |
|
| ExclusionCriteria |
| Details |
pregnant women with Hb less than 7gm%.
Anemia due to pathology like Malignancies, lead poisoning,Thalassemia, Sideroblastic anemia, Hereditory spherocytosis,sickel cell anemia,Aplastic Anemia, Haemolytic anemia.
patient with occult blood positive in stool examination
pregnant women with knoww case of Tuberculosis, asthma, thyroid, hypertension diabetes mellitus, haemorriods, bleeding per rectum ,per vagina, jaundice.
pregnant women in their first and last trimester
multiple pregnancy, pregnancy induced complications like hyperemesis gravidarum, antepartum haemorrhage ,pre eclampsia, toxaemia , eclampsia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase Hemoglobin Concentration in blood |
before treatment and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Reduce Signs and symptoms |
on 30th day and 60th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/08/2024 |
| 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 Present Title ’’A clinical study to evaluate the effect of loha gudhadi gutika in the management of garbhini pandu w.s.r to Iron deficiency anemia in pregnancy ’’ will be Conducted on 40 Pregnant womens with 20 in each group with Mentioned objective and subjective Parameters. One group will be treated with loha gudhadi gutika 500mg BD with water and othergroup will be treated with Ferrous Ascorbate (Tab.OROFER XT).Assessment and investigations will be done before and after treatment.( 60th day). |