| CTRI Number |
CTRI/2025/08/093126 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Ayurvedic Cookies in reducing Vomiting during Pregnancy |
|
Scientific Title of Study
|
An exploratory single arm open label clinical study to evaluate the effect of Bilwa Lajadi cookie for nausea and vomiting in pregnancy |
| 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 Shivani Dhepe |
| Designation |
PG Scholar |
| Affiliation |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate studies And Research Centre |
| Address |
Room number 23
Department of Streeroga And Prasuti Tantra
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and research Centre Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9503473675 |
| Fax |
|
| Email |
shivani.dhepe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayasheela Goni |
| Designation |
Professor |
| Affiliation |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate studies And Research Centre |
| Address |
Room number 23
Department of Streeroga And Prasuti Tantra
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and research Centre Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9481724067 |
| Fax |
|
| Email |
jay300672@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayasheela Goni |
| Designation |
Professor |
| Affiliation |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate studies And Research Centre |
| Address |
Room number 23
Department of Streeroga And Prasuti Tantra
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and research Centre Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9481724067 |
| Fax |
|
| Email |
jay300672@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Shivani Dhepe |
| Address |
PG Scholar
Department of Streeroga and Prasuti Tantra
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre Belagavi Karnataka India 590003 |
| 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 Shivani Dhepe |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka 590003 |
Room number 23
General Prasuti OPD
Department of Streeroga and Prasuti Tantra
Belgaum
KARNATAKA |
9503473675
shivani.dhepe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee for Reseach on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Bilwa Lajadi Cookie, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 8(g), Frequency: qid, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: The dosage form is a cookie as it is not available in drop down menu modaka is selected |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Primi and multi gravida up to G2 P1between 18 to 35 years of age with symptoms of nausea and vomiting in first trimester
2 Patient having confirmed diagnosis of pregnancy 3 Patient having ANC profile CBC Blood Group Urine Routine RBS Early pregnancy USG scan Viability scan
|
|
| ExclusionCriteria |
| Details |
1 Multigravida with more than second parity and with bad obstetric history
2 Pregnant women with symptoms of hyperemesis gravidarum dehydration twin pregnancy and molar pregnancy
3 Diagnosed cases of diabetes mellitus hypertension anaemia and hypothyroidism during pregnancy
4 History of peptic ulcer appendicitis hepatitis pancreatitis presenting with vomiting
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nausea and Vomiting assessed by Pregnancy Unique Quantification of Emesis score |
Baseline 15th day 30th day and 45 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life Assessment by Nausea Vomiting in pregnancy questionnaire NVPQOL |
Baseline 15th day 30th day and 45 th day |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/12/2025 |
| 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="6"
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
|
Nausea and vomiting of pregnancy NVP is one of the most common medical conditions affecting approximately 50 to 80 percentage of pregnant women during the first trimester is also known vyakta garbha lakshana in AyurvedaThough typically considered a physiological adaptation NVP can significantly impact a womans physical health emotional well being nutritional intake and overall quality of life In more severe cases it may lead to complications such as dehydration weight loss and hospitalization While modern antiemetics are available concerns regarding fetal safety and maternal side effects prompt many pregnant women to seek natural dietary or Ayurvedic alternatives Traditional Ayurvedic texts recommend Bilwa Aegle marmelos Laja puffed rice and other herbs for balancing digestive fire and managing emesis in pregnancy This study proposes the development and clinical evaluation of an Ayurveda based functional food Bilwa Lajadi Cookie as a novel palatable and safe dietary intervention for NVP The cookie is intended to provide symptomatic relief while ensuring nutritional support during early pregnancy
|