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

NEED OF THE STUDYØ  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.

 Ã˜  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- AIMTo 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 Objective1) 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 QUESTIONResearch 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 (H****A): 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 StudyFollowing material & method will be employed for conducting the present research work

a. SelectionofCases:

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 CRITERIAClinical parameters:

A.Ultrasonography for fetal wellbeing1. Fetal biometry –

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