| CTRI Number |
CTRI/2025/02/080329 [Registered on: 11/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| 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 Dietary regimen in 4th-7th month of pregnancy. |
|
Scientific Title of Study
|
Evaluation of add on clinical efficacy of Masanumasik Dietary regimen as Garbhini Rasayana in 4th-7th month of Pregnancy: A randomised control 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 |
Richa Rani |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda (AIIA) |
| Address |
OPD -203, 2nd Floor, Hospital building,All India Institute of Ayurveda (AIIA) Mathura Road, Gautam Puri Sarita Vihar, Delhi - 110076
South
DELHI
110076
India |
| Phone |
09667585374 |
| Fax |
|
| Email |
richarani1908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Pandey |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda (AIIA) |
| Address |
Prasuti Tantra evam Stree Roga Department,4th floor, Block C,All India Institute of Ayurveda (AIIA) Mathura Road, Gautam Puri Sarita Vihar, Delhi - 110076
South
DELHI
110076
India |
| Phone |
7905824977 |
| Fax |
|
| Email |
drmeenakshipathak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa Rani |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
OPD -203, 2nd Floor, Hospital building,All India Institute of Ayurveda (AIIA) Mathura Road, Gautam Puri Sarita Vihar, Delhi - 110076
South
DELHI
110076
India |
| Phone |
09667585374 |
| Fax |
|
| Email |
richarani1908@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda
gautam puri
Mathura road
Sarita Vihar
New Delhi 110076
India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda (AIIA) Mathura Road, Gautam Puri Sarita Vihar, Delhi - 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Richa Rani |
All India Institute of Ayurveda |
OPD -202, 2nd Floor, Hospital building,All India Institute of Ayurveda (AIIA) Mathura Road, Gautam Puri Sarita Vihar, Delhi - 110076
South
DELHI |
09667585374
richarani1908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translational research and Biostatistics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:1||Obstetrics. Ayurveda Condition: GARBAVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Calcium (elemental), Iron (elemental) | Calcium (elemental) 200 mg orally
Iron (elemental) 30 mg orally
frequency bd 4 months duration
reference Standard WHO ANC Protocol | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:Ksheer200ml with Shunthi powder 250 g with Sarpi 10ml
oral route frequency BD duration 1 month
refrence charak samhita sharir sthana 7 chapter 32 shloka
, Other:Ksheer200ml with Shunthi powder 250 with Navneet 10gm
oral route BD frequency 1 month duration
Shatavari Siddha Ghritam 10 ml
oral route BD frequency 2 months duration
refrence Charak Samhita Sharir Sthana 7 Chapter 32 shloka
, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Primi gravida with gestational age 11-12 weeks.
2. Age group 20 -35 years.
3. Able and willing to participate and provide signed informed consent.
|
|
| ExclusionCriteria |
| Details |
Pregnant women with
Dyslipidemia, Deranged LFT, Hemoglobin less than 7gm/dl, severe systemic disease, uncontrolled hypertension (Bp greater than or equal to 140/90mmhg), diabetes mellitus (FBS more than 100mg/dl).
Diagnosed cases of disorders of reproductive tract like tuberculosis, carcinoma, and uterine fibroid and STDs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Garbhini Masanumasika Paricharya on foetal growth parameters and maternal wellbeing (maternal weight gain) |
28th week and 40th week of ante natal period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Garbhini Masanumasika Paricharya on-
• nausea and vomiting
• Constipation
• Insomnia
• Fatigue
• Oedema
|
28th weeks of ante natal period |
|
|
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 3 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="0"
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
|
Contemporary medicine typically
addresses prenatal nutritional deficiencies through targeted supplementation
(e.g., iron, calcium, folate). In contrast, traditional Ayurvedic medicine
emphasizes a holistic approach, focusing on enhancing overall digestive
function and utilizing natural substances considered ’Rasayanas’ to promote
maternal and fetal health. [i]
Rasayanas are believed to provide enhanced nutrition and support optimal
biological function.
Systematic prenatal care, known as Garbhini
Masanumasik Pathya in Ayurveda, involves the regular monitoring of a
pregnant woman’s health through counseling on diet, lifestyle, and other
factors.[ii]
This personalized care should
begin early in pregnancy and continue until childbirth. Optimal Garbhini Paricharya
supports healthy foetal development, maternal wellbeing, a successful delivery,
and a smooth postpartum recovery. Ayurvedic texts prescribe specific
dietary regimens and lifestyle recommendations tailored to each month of
pregnancy, emphasizing the crucial role of nutrition in prenatal care.
Primary objective
To evaluate the effect of Garbhini
Masanumasika Paricharya on foetal growth parameters and maternal wellbeing
(maternal weight gain) during 4-7th month of pregnancy
Secondary objective
To evaluate the effect of Garbhini
Masanumasika Paricharya on-
·
nausea
and vomiting
·
Constipation
·
Insomnia Fatigue · Oedema
|
STUDY DESIGN
|
Open label Randomised Clinical Trial
|
|
RANDOMISATION
|
Computer generated randomisation
|
|
TIMING
|
Prospective
|
|
SAMPLE SIZE
|
28 in each group
|
|
NUMBER of GROUPS
|
2
|
|
PURPOSE
|
Analysis
|
|
DURATION OF STUDY
|
120 Days
|
|
FOLLOW UP
|
Every 15th day during the course of intervention
and once after delivery
|
·
|
Before
intervention
|
After
intervention
|
|
CBC with ESR
|
CBC
with ESR
|
|
Lipid
profile
|
Lipid
profile
|
|
FBS
|
Serum
Calcium
|
|
Serum
Calcium
|
USG
(Obs.)(COLOUR DOPPLER)( After 28th week)
|
|
Sr.
protein
|
Sr.
protein
|
|
Omega
3 fatty acid, Omega 6 fatty acid
|
Omega
3 fatty acid, Omega 6 fatty acid
|
|
USG (Obs.) (NT/NB) (At 10th -12th
week)
|
|
|
LFT, KFT
|
|
|
GROUPS
|
INTERVENTION
|
DOSAGE
|
Anupana
|
TIME
|
DURATION
|
|
Control
|
Calcium (elemental)
Iron (elemental)
|
200 mg (orally)
30 mg
(Orally)
|
Water
|
BD
|
120 Days
|
|
Trial
|
Calcium (elemental)
Iron (elemental)
|
200 mg
(Orally)
30 mg
(Orally)
|
Water
|
BD
|
120 Days
|
|
4th Month – Ksheer (with Shunthi powder 250
g) +
Navneet
5th Month – Ksheer (with Shunthi powder 250
g) +
Sarpi
6th and 7th Month – Shatavari Siddha Ghritam
|
200 ml[i]
+
10 gms
(Orally)
200 ml
+
10 ml
(orally)
10 ml
(orally)
|
|
BD
|
30 days
30 days
60 days
|
|