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CTRI Number  CTRI/2024/05/067992 [Registered on: 28/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of ayurvedic trial drugs in pregnancy 
Scientific Title of Study   A randomized comparative trial to evaluate the role of bala beeja granules and jeevanti granules in fetal and maternal wellbeing w.s.r to garbhini paricharya in second trimester  
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 Pooja Dadhich 
Designation  Pg Scholar 
Affiliation  National Institute Of Ayurveda Deemed To Be University (De Novo) Jaipur Rajasthan 
Address  Room No 304 3rd Floor Department Of Prasuti Tantra Evum Stri Roga National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8426081618  
Fax    
Email  poojadadhich293@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR B Pushpalatha 
Designation  Professor 
Affiliation  National Institute Of Ayurveda Deemed To Be University (De Novo) Jaipur Rajasthan 
Address  Room No 304 3rd Floor Department Of Prasuti Tantra Evum Stri Roga National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9413206790  
Fax    
Email  pushpalathania@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Dadhich 
Designation  Pg Scholar 
Affiliation  National Institute Of Ayurveda Deemed To Be University (De Novo) Jaipur Rajasthan 
Address  Room No 304 3rd Floor Department Of Prasuti Tantra Evum Stri Roga National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8426081618  
Fax    
Email  poojadadhich293@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jaipur Rajasthan 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda jaipur Rajasthan 
Address  National Institute of Ayurveda Deemed to be University (De novo) Madhav vilas palace jaipur Rajasthan(302002) 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pooja Dadhich  National Institute Of Ayurveda And Associated Hospitals  Department Of Prasuti Tantra Evum Stri Roga National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN 		 8426081618

poojadadhich293@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute Of Ayurvveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Bala Beeja Granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: MILK), Additional Information: Morning 9:00AM Evening 5:00 PM
2Comparator ArmDrugOther than Classical(1) Medicine Name: Jeevanti , Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: milk), Additional Information: Morning 9:00 Am Evvening 9:00 Pm
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Pregnant woman of 13-14th week of pregnancy aged 21-40 years.
2.H/o Recurrent abortion
3.Previous Bad Obstetric History (BOH)
4.Pregnancy after infertility
 
 
ExclusionCriteria 
Details  1.Hemoglobin below 9gm/dl
2.Multiple pregnancy
3.Pregnancy with uterine fibroid and carcinoma.
4.Pregnancy with Cardiovascular diseases.
5.Pregnancy with any severe systemic illness.
6.Pregnancy with uterine malformation &
congenital defect of uterus.
• Pre existing diabetes mellitus,
Hypertension
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Fetal wellbeing - Fetal biometry with USG-

• Biparietal diameter (BPD)
• Head circumference (HC)
• Abdominal circumference (AC)
• Femur length (FL)
• AFI (Amniotic fluid index)
• Estimated Fetal Weight
2 Color Doppler findings -
• Pulsatility index
• Resistive index
• Umbilical arterial S/D ratio ( Systolic velocity /Diastolic velocity)
 		 120 days
 
 
Secondary Outcome  
Outcome  TimePoints 
1)Rate of occurrence of major disorders like Pregnancy Induced Hypertension, Gestational Diabetes & Rate of minor maternal ailments
2)Maternal well being – assessed with Mid Upper Arm Circumference, Pregnancy Weight Gain, Blood Pressure, Maternal Blood Sugar Levels
 		 16 week ( 4month) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/06/2024 
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="0"
Months="4"
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  

NEED OF THE STUDY

Ø  Food supplementation in terms of micronutrients is extremely important during pregnancy for the correct growth and development of the fetus because of the high nutritional needs in pregnancy.

 

Ø  The risks associated with pregnancy, childbirth and poor nutrition all contribute to maternal deaths. India has a relatively high infant mortality rate that is mostly attributed to deprivation of the nutrition and rising incidence of preterm delivery, IUGR and low birth weight.

 

That’s why current study is planned.

AIM & OBJECTIVES- AIM

To evaluate the efficacy of Bala Beeja Granules and Jeevanti Granules in fetal & Maternal wellbeing in second trimester of pregnancy.

Primary Objective

·         To evaluate and compare the efficacy of Bala Beeja Granules and Jeevanti Granules

in fetal and Maternal wellbeing in second trimester of pregnancy.

 

Secondary Objective

1)  To evaluate and compare the efficacy of Bala Beej Granules and Jeevanti Granules in minor ailments and complications during second trimester of pregnancy.

2)  To evaluate and compare the efficacy of Bala Beej Granules and Jeevanti Granules in fetal wellbeing during second trimester of pregnancy.

RESEARCH QUESTION

Research Question: Is there any difference between efficacy of Bala Beeja Granules and Jeevanti Granules in fetal & maternal wellbeing in second trimester of pregnancy?

HYPOTHESIS

Null Hypothesis (H)0 : There is no difference in the efficacy of Bala Beeja Granules and

Jeevanti Granules in fetal and Maternal wellbeing in second trimester of pregnancy.

 

 

Alternative Hypothesis (HA): There is difference in the efficacy of Bala Beeja Granules

and Jeevanti Granules in fetal and Maternal wellbeing in second trimester of pregnancy.

 

PLAN OF THE STUDY MATERIALS& METHODS-

Literary Study

Literary references are collected from Ayurveda classics, commentaries, modern literature; published articles from research journals available in the institutes Library/departmental Library, online journal available at PubMed, central, AYUSH research portal, Google scholar, Science Direct etc.

2.  Clinical Study

Following material & method will be employed for conducting the present research work

a.      Selection of Cases:

60 registered patients of ANC fulfilling the inclusion criteria will be randomly selected from OPD and IPD Arogyashala of P.G. dept. of Prasuti tantra evum stri roga section of NIA Jaipur. Patients will be selected irrespective of caste, religion, nationality, socioeconomic status.

b.      Diagnostic Criteria Inclusion criteria:

·         Pregnant woman of 13-14th week of pregnancy aged 21-40 years.

·         H/o Recurrent abortion

·         Previous Bad Obstetric History (BOH)

·         Pregnancy after infertility

Exclusion criteria:

·         Hemoglobin below 9gm/dl

·         Multiple pregnancy

·         Pregnancy with uterine fibroid and carcinoma.

·         Pregnancy with Cardiovascular diseases.

·         Pregnancy with any severe systemic illness.

·         Pregnancy with uterine malformation & congenital defect of uterus.

·         Pre existing diabetes mellitus, Hypertension.

 

STUDY DESIGN

·         Total duration of trial: 16 weeks

·         Follow up: The patient will be advised to report every four weeks.

·         Study type: A Single Blind Randomized Comparative Trial

·         Method of generating randomization sequence: Computer Generated

·         Allocation concealment method: SNOSE (Sequentially-Numbered, Opaque, Sealed, Envelope)

·         Masking: Single Blind

·         Timing: Prospective

·         Number of Groups: 2

·         Source of Data (Population of interest): IPD and OPD of NIA

·         Sample size: 60(30 patients in each group)

·         End point: Efficacy

Details of Drugs/intervention: The drug bala beej granules and jeevanti granules will be prepared in GMP certified Nageshwar pharmacy of NIA


Methods of administration of therapy/drug:

First of all, detail of study will be explained to the pregnant ladies. Screening test will be conducted. Written consent will be taken, from the patients who fulfill the inclusion and exclusion criteria. Then demographic data will be taken. Bala Beeja Granules and Jeevanti Granules will be given throughout second trimester of pregnancy.

 

 

Groups

(30 patients in each group)

Drug

Dose

Time of Administration

Route

Anupana

Duration

A

Bala Beeja Granules

10gm BD

per day

30   min    after Food

{9:00 AM & 9:00PM}

Oral

Godugdha

16 weeks

B

Jeevanti Granules

10gm BD

per day

30   min    after Food

{9:00 AM & 9:00PM}

Oral

Godugdha

16 weeks

 

Routine care will be continue according to standard Ayurvedic protocol.The patient will be advised to report every four weeks.

LABORATORY INVESTIGATIONS:

 

Before Treatment

1.  Complete Blood Count (CBC)

2.  Total Leucocyte Count (TLC)

3.  Fasting Blood Sugar (FBS)

4.  Liver function test (LFT)

5.  Renal function test (RFT)

6.  Human Immuno-Deficiency Virus (HIV)

7.  Venereal disease research laboratory (VDRL)

8.  Hepatitis B surface Antigen (HbsAg), HCV

9.      Urine routine & microscopic

10.  USG for fetal wellbeing

11.    DIPSI

During treatment: Anomaly scan at 20th week for

1.  Fetal parameter (BPD,HC,AC,FL)

2.  Amniotic fluid

3.  Estimated fetal weight

After Treatment:

1.      Hemoglobin %

2.      FBS

3.      Liver function test (LFT)

4.      Renal function test (RFT)

5.      USG for fetal biometry

6.      Color Doppler

WITHDRAWL CRITERIA

·         If any serious condition like Gestational Diabetes Mellitus, Severe Pregnancy Induced Hypertension, Eclampsia etc. develops during the course of trial which requires urgent treatment.

·         If the patient wants to withdraw from clinical trial by herself.

·         Patient with irregular follow up and non-compliance.

 

Adverse drug reaction (ADR): Any adverse event, observed during treatment period or during follow up visits will be clearly documented using ADR Form (attached) and appropriate and timely management will be done consulting the physician associated in the trial. The Investigating team will report the same to the Ethics committee at the earliest.

Any other illness during trial: Patient will be advised to take medicine from related consultant for one week.


Methods of administration of therapy/drug:

First of all, detail of study will be explained to the pregnant ladies. Screening test will be conducted. Written consent will be taken, from the patients who fulfill the inclusion and exclusion criteria. Then demographic data will be taken. Bala Beeja Granules and Jeevanti Granules will be given throughout second trimester of pregnancy.

 

 

Groups

(30 patients in each group)

Drug

Dose

Time of Administration

Route

Anupana

Duration

A

Bala Beeja Granules

10gm BD

per day

30   min    after Food

{9:00 AM & 9:00PM}

Oral

Godugdha

16 weeks

B

Jeevanti Granules

10gm BD

per day

30   min    after Food

{9:00 AM & 9:00PM}

Oral

Godugdha

16 weeks

 

Routine care will be continue according to standard Ayurvedic protocol.The patient will be advised to report every four weeks.

LABORATORY INVESTIGATIONS:

 

Before Treatment

1.  Complete Blood Count (CBC)

2.  Total Leucocyte Count (TLC)

3.  Fasting Blood Sugar (FBS)

4.  Liver function test (LFT)

5.  Renal function test (RFT)

6.  Human Immuno-Deficiency Virus (HIV)

7.  Venereal disease research laboratory (VDRL)

8.  Hepatitis B surface Antigen (HbsAg), HCV

9.      Urine routine & microscopic

10.  USG for fetal wellbeing

11.    DIPSI

During treatment: Anomaly scan at 20th week for

1.  Fetal parameter (BPD,HC,AC,FL)

2.  Amniotic fluid

3.  Estimated fetal weight

After Treatment:

1.      Hemoglobin %

2.      FBS

3.      Liver function test (LFT)

4.      Renal function test (RFT)

5.      USG for fetal biometry

6.      Color Doppler

WITHDRAWL CRITERIA

·         If any serious condition like Gestational Diabetes Mellitus, Severe Pregnancy Induced Hypertension, Eclampsia etc. develops during the course of trial which requires urgent treatment.

·         If the patient wants to withdraw from clinical trial by herself.

·         Patient with irregular follow up and non-compliance.

 

Adverse drug reaction (ADR): Any adverse event, observed during treatment period or during follow up visits will be clearly documented using ADR Form (attached) and appropriate and timely management will be done consulting the physician associated in the trial. The Investigating team will report the same to the Ethics committee at the earliest.

Any other illness during trial: Patient will be advised to take medicine from related consultant for one week.

ASSESSMENT CRITERIA

Clinical parameters:

 

A.Ultrasonography for fetal wellbeing

1. Fetal biometry –

 

·           Biparietal diameter (BPD)

·         Head circumference (HC)

·         Abdominal circumference (AC)

·         Femur length (FL) 2.Amniotic fluid

3. Estimated fetal body weight 4.Color Doppler parameter-

Ø  Pulsatility index

Ø  Resistive index

Ø  Umbilical arterial S/D ratio ( Systolic velocity /Diastolic velocity)

 

All the measurements taken will be compared with the standard measures such as    estimated fetal weight percentile chart, fetal growth percentile chart1 and ultrasound.

1.      Maternal findings

·         Pregnancy weight gain

·         Mid upper arm circumference

·         Month wise abdominal girth in centimeters

·           SFH (Symphysis Fundal Height) in centimeters after 24 weeks

2.      Maternal Ailments

·         Constipation (Malabandh)

·         Low back ache (Kati shoola)

·         General debility (Dourbalya)

·         Pallor (Panduta)

·         Heaviness of body (Anga-gaurava)

·         Pedal edema (Pada- shotha)

·         Palpitation (Hrida-drava)

·         Anorexia (Aruchi)

 

 

 


1 https://intergrowth21.tghn.org

Ethical issues:

The study will be conducted according to the prevalent standards of Good Clinical Practice

Ø  This protocol submitted and any amendments will be to Institutional Ethics Committee(IEC) for approval of the study conduct.

Ø  The Study will be registered in C.T.R.I.

Ø  Performa, Scale or Questionnaire: adopted

Ø  Statistical test to be used: Based on normality and type of data parametric and non- parametrictest will be used.



 

 
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