| CTRI Number |
CTRI/2024/07/071388 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| 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
|
A Clinical Trial to Evaluate the Effect of Madhura Aushad Siddha Khanda Kalpana as Rasayana during 6th and 7th month of Pregnancy |
|
Scientific Title of Study
|
A Randomised comparative Clinical trial to Evaluate the Effect of Madhura Aushad siddha khanda kalpana as rasayana during 6th And 7th Month of Pregnancy w.s.r. to the maternal and Fetal Outcome |
| 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. Shireen Taj Patel |
| Designation |
Post Graduate Scholar in Prasuti Tantra Evam Stree Roga |
| Affiliation |
Dr. N.A Magadum Ayurvedic Medical College,Hospital And Research Centre,Ankali-591213 |
| Address |
Dr. N.A Magadum Ayurvedic Medical College,Hospital And Research Centre,Ankali-591213
Taluk-Chikodi,Dist-Belgaum
Belgaum
KARNATAKA
591213
India |
| Phone |
7760347274 |
| Fax |
|
| Email |
patelshireen9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Laxmi M Pattan |
| Designation |
Associate Professor |
| Affiliation |
Dr. N.A Magadum Ayurvedic Medical College,Hospital And Research Centre,Ankali-591213 |
| Address |
Departments of Prasuti Tantra Evam Stree Roga
Dr. N.A Magadum Ayurvedic Medical College,Hospital And Research Centre,Ankali-591213
Belgaum
KARNATAKA
591213
India |
| Phone |
9480792115 |
| Fax |
|
| Email |
drlaxmipattan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi M Pattan |
| Designation |
Associate Professor |
| Affiliation |
Dr. N.A Magadum Ayurvedic Medical College,Hospital And Research Centre,Ankali-591213 |
| Address |
Departments of Prasuti Tantra Evam Stree Roga
Dr.N.A.Magadum Ayurvedic Medical College Hospital and Research Center Ankali - 591213
TALUK-CHIKODI,DIST-BELGAUM
Belgaum
KARNATAKA
591213
India |
| Phone |
9480792115 |
| Fax |
|
| Email |
drlaxmipattan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali |
|
|
Primary Sponsor
|
| Name |
Dr Shireen taj patel |
| Address |
Dr. N.A.Magadum Ayurvedic Medical College,Hospital and Research Center, Ankali-591213 Taluk-chikodi, Dist-Belgaum |
| 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 Shireen Taj Patel |
Dr.N A Magadum Ayurvedic Medical College Hospital and Research Cneter ,Ankali |
Department of Prasuti Tantra Evam Stree Roga
Dr.N.A.Magadum Ayurvedic Medical College,Hospital and Research Cneter ,Ankali-591213, Taluk-chikodi, Dist- Belgaum
Belgaum
KARNATAKA |
7760347274
patelshireen9@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 Center Ankali - 591213 Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O269||Pregnancy related conditions, unspecified. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhura Aushad Siddha Khand Kalpana (Granules), Reference: Caraka Samhita ,Vimana Sthana Rogabhishagjitiya Vimana Adhyaya: Chapter 8, Verse 139, Route: Oral, Dosage Form: Khanda /Granules, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: The medicine in form of granules will be administered with milk for twice a day after food
| | 2 | Comparator Arm (Non Ayurveda) | | - | Routine ANC | Routine Ante-Natal care with Iron (100mg of Elemental iron) and Calcium, Once a day-OD after food for 60days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Both primi and multi gravida with completed 5th month of pregnancy.
Age 18years to 35 years
Hb more than 8gm/dl |
|
| ExclusionCriteria |
| Details |
Pregnancy complicated with Pregnancy Induced Hypertension(PIH),Gestational Diabetic Mellitus(GDM),Amniotic Fluid Disorder Oligohydraminos or polyhydraminos,Abnormal Anomaly scan,Cervical Incompetency, FGR(fetal growth restriction),Pregnancy with Antepartum Haemorrhage.
Pregnancy with HB less than 8gm/dl
Maternal systemic disease such as k/c/o Hypertension, Diabetes Mellitus,Thyroid Dysfunction,Thalassemia,Asthma ,Epilepsy,Cardiovascular system,Central nervous system.
Previous history of Intra Uterine Death(IUD),Abortion, Bad Obstetrics History, Multiple Pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
rasayana assessment will be based on following subjective and objective criteria i.e
subjective criteria : maternal -Tiredness, constipation,distrubed sleep,pallor,anorexia,fatigue,backache,leg cramps
objective criteria:
maternal weight,Hb%
TAS for fetal growth parameters like BPD(Biparietal Diameter,HC-head circumference), AC (abdominal circumference),FDL- (Femoral Diaphysis length), EFW-(estimated fetal weight) |
60 days of Drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal weight
and TAS for fetal growth parameters like BPD(Biparietal diameter) ,AC (abdominal circumference), HC ( head circumference),
FDL ( femoral diaphysis length),EFW (estimated fetal weight) |
60 days |
|
|
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)
|
05/08/2024 |
| 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 Yet Recruiting |
| 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 Randomised Comparative Clinical Trial to Evaluate the Effect of Madhura Aushad Siddha Khanda Kalpana as Rasayana during 6th and 7th month of Pregnancy w.s.r. to the Maternal and Fetal Outcome’’ a clinical study with total number of 40 registered pregnant women with their completed 5th month of pregnancy will be selected and randomly allocated into 2 groups in each 20. 20 pregnant women completing their 5th month of pregnancy will be randomly alloted in 2 groups . Group A will be administered with Madhura Aushad Siddha Khanda Kalpana 12gm BD with Milk Group B will be administered with Routine Antenatal Care supplement of IRON and CALCIUM. Assessment will be done with subjective objective criteria and investigations before and after treatment i.e 60th day. |