| CTRI Number |
CTRI/2023/07/055890 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
29/07/2023 |
| 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 study to evaluate the effect of Garbhini Ksheerakashayas for maternal and fetal nourishment in 7th 8th and 9th month of pregnancy |
|
Scientific Title of Study
|
A Randomized open-labelled controlled clinical study to evaluate the efficacy of Garbhini Ksheerapakas for Garbha Poshana in 7th, 8th & 9th month of pregnancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devika Srinivasan Divakaran |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital,
Kanakapura Road,
Udayapura P.O,
Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
8904462503 |
| Fax |
|
| Email |
devika9797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachana HV |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital,
Kanakapura Road,
Udayapura P.O,
Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9535744077 |
| Fax |
|
| Email |
dr.rachanabhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devika Srinivasan Divakaran |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital,
Kanakapura Road,
Udayapura P.O,
Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
8904462503 |
| Fax |
|
| Email |
devika9797@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Devika Srinivasan Divakaran |
| Address |
Sri Sri College of Ayurvedic Science and Research, Kanakapura Road, Udayapura P.O, 560082 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Sri College of Ayurvedic Science and Research |
Kanakapura Road
Udayapura PO
560082 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devika Srinivasan Divakaran |
Sri Sri College of Ayurvedic Science and Research Hospital |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital,
Kanakapura Road,
Udayapura P.O,
Bangalore-560082
Bangalore
KARNATAKA |
8904462503
devika9797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:1||Obstetrics. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yava Siddha Ksheerapaka, Reference: Sahasrayogam, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: GROUP A
25th-28th week of gestation(7th month of Pregnancy)(2) Medicine Name: Morata Siddha Ksheerapaka, Reference: Sahasrayogam, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: GROUP A
29th-32nd week of gestation (8th month of Pregnancy)(3) Medicine Name: Shatavari Siddha Ksheerapaka, Reference: Sahasrayogam, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: GROUP A
33rd-36th week of gestation (9th month of Pregnancy) | | 2 | Comparator Arm (Non Ayurveda) | | - | | Ferrous Ascorbate 100mg 1 OD After food X 3 months
Calcium Carbonate 500mg 1 OD After food X 3 months |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Primigravida and Multigravida
2) Subjects who have just completed 24 weeks of gestational age.
3) Subjects having haemoglobin value of 10 g/dL or more.
4) Subjects who are willing to give written consent for the study.
|
|
| ExclusionCriteria |
| Details |
1) Subjects up to 24 weeks of gestational age.
2) Systemic diseases like Hypertension, Diabetes Mellitus, Severe Anaemia, Thyroid disorders.
3) High risk pregnancies like Pre-eclampsia, Gestational Diabetes, Ante-partum Haemorrhage, Polyhydramnios.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
-Improvement in Subjective symptoms: Fatigue, Pedal Oedema, Backache, Heart Burn, Malapravritti, Heaviness of body (Anga Gourava)
-Improvement in Objective parameters: Haemoglobin (g/dL), Maternal Weight Gain (kg),Fundal Height (cm), Abdominal Circumference (cm), Foetal Weight (g), USG findings: Femur length, Abdominal Circumference, Head Circumference, Amniotic fluid Index
-Mode of Delivery- Normal delivery
|
Pre-test Assessment- 0th Day (Before 28 weeks)
1st Assessment- After completion of 28 weeks
2nd Assessment- After completion of 30 weeks
3rd Assessment- After completion of 32 weeks
4th Assessment- After completion of 34 weeks
5th Assessment- After completion of 36 weeks
1st Follow up- Weekly once till delivery after 36 weeks
2nd Follow up- At the time of Delivery
3rd Follow up- 7 days post delivery
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
-Improvement in Objective parameters: Haemoglobin (g/dL), Maternal Weight Gain (kg),Fundal Height (cm), Abdominal Circumference (cm), Foetal Weight (g), USG findings: Femur length, Abdominal Circumference, Head Circumference, Amniotic fluid Index
-Mode of Delivery- Normal delivery |
Pre-test Assessment- 0th Day (Before 28 weeks)
1st Assessment- 30th week
2nd Assessment- 36th week
3rd Assessment- After Delivery |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/08/2023 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [devika9797@gmail.com].
- For how long will this data be available start date provided 17-04-2025 and end date provided 17-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Pregnancy is one of the crucial phase in a woman’s life during her journey towards motherhood. As per a recent National survey study in India, it was estimated that 1.3 million Indian women have died from maternal causes over the last two decades.
Maternal health is maintained by following Garbhini Paricharya i.e., a systemic lifestyle and diet regimen along with various Ayurvedic formulations told in the classics. Along with Masanumasika Pathya, Garbhini Paricharya includes Garbhasthapaka Dravyas or drugs which are beneficial for the maintenance of Pregnancy and Garbhopaghatakara Bhavas which lists the factors that are harmful to the foetus and should be avoided by the pregnant woman.
Sahasrayogam and Arogyakalpadruma are two important Ayurvedic texts which have exclusive references on Garbhini Ksheerapakas. As per this reference, different drugs in the form of Ksheerapaka are advocated month-wise throughout pregnancy.
In the 7th month, Yava Siddha Ksheerapaka is advised as it is a good source of micro and macro-nutrients maintaining adequate Garbha Poshana and actively stimulates foetal development especially lungs and kidney. As it is bulk promoting it helps to relieve constipation and due to its diuretic effect, it relieves pedal oedema which is commonly seen in the third trimester.
Morata Siddha Ksheerapaka is told for the 8th month as it acts as Tridosha Shamana and has anti-bacterial properties. Morata is proved to act as a skeletal muscle relaxant and thereby relieves backpain due to the increasing weight of the gravid uterus.
As
the ninth month begins, the woman enters to her Prasava Kala. Shatavari Siddha Ksheerapaka due to its Madhura Rasa and Madhura
Vipaka acts as a good galactagogue and has immunomodulatory effect.
Hence, this study is intended to evaluate the efficacy of Garbhini Ksheerapakas for Garbha Poshana in the 7th, 8th and 9th month of pregnancy.
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