| CTRI Number |
CTRI/2025/03/082874 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Ayurvedic drug and Allopathy drug to control Pregnancy-Induced Vomiting |
|
Scientific Title of Study
|
A Comparative Clinical Study on the Effect of Dhanyaka Kalka with Anupana of Sharkara mixed Tandulodaka and doxylamine in Garbhini Chardi |
| 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 Nayana Bhagat |
| Designation |
Associate Professor |
| Affiliation |
KAHER University |
| Address |
KAHERs Shri BMK Ayurved Mahavidyalaya
Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
8123236686 |
| Fax |
|
| Email |
nayanag.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Bhagat |
| Designation |
Associate Professor |
| Affiliation |
KAHER University |
| Address |
KAHERs Shri BMK Ayurved Mahavidyalaya
Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
8123236686 |
| Fax |
|
| Email |
nayanag.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayana Bhagat |
| Designation |
Associate Professor |
| Affiliation |
KAHER University |
| Address |
KAHERs Shri BMK Ayurved Mahavidyalaya
Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
8123236686 |
| Fax |
|
| Email |
nayanag.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| KAHER University, Neharu Nagar Belagavi, Karnataka, India Pin: 590001 |
|
|
Primary Sponsor
|
| Name |
KAHER University |
| Address |
Neharu Nagar Belagavi Karnataka India Pin: 590001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KAHER |
Shri BMK AMV Belagavi Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayana Bhagat |
KLE Ayurveda Hospital |
PTSR Department Prasooti Tantra,
Room No. 23, Shahapur Belagavi
Belgaum
KARNATAKA |
8123236686
nayanag.kaher@kleayurworld.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O00-O9A||Pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhanyak Kalka, Reference: Prasooti Tantra evam Stree roga part 1 Chapter 06 Garbhin vyadhiyan evam unki chikitsa page no, 249, sloka 11, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Tandulodaka), Additional Information: Tandulodaka 80ml BID | | 2 | Comparator Arm (Non Ayurveda) | | - | Doxylamine | Orally 10mg BID after food for 14 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
First-trimester |
|
| ExclusionCriteria |
| Details |
Subjects in whom Chardi is seen in second and third trimester of Pregnancy.
Subjects with Hyperemesis gravidarum.
Subjects with twin pregnancy.
Subjects with vesicular mole.
Vomiting caused due to other systemic disorders like peptic ulcer, appendicitis etc.
Subjects suffering from severe infections.
Subjects suffering from chronic systemic diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Control vomiting |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/03/2037 |
| 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 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
|
•Garbhini Chardi, commonly
known as vomiting during pregnancy, poses significant challenges to maternal
health and well-being. This condition, characterized by frequent and persistent
vomiting episodes, can lead to dehydration, malnutrition, electrolyte
imbalances, and overall diminished quality of life for pregnant women. While
various treatments exist, including antiemetic medications, dietary
modifications, and intravenous fluids, they often provide incomplete relief and
may carry risks for both maternal and fetal health
•Ayurveda,
offers alternative approaches to managing Garbhini Chardi. One such formulation is Dhanyaka Kalka with Anupana of Sharkara mixed Tandulodaka ( Yogaratnakar streerogachikitsa). Dhanyaka, also known
as coriander, possesses digestive, carminative, and antiemetic properties in
Ayurveda.
.•Traditional
Ayurvedic texts emphasize the importance of administering treatments that are
easily palatable and preferred by the patient, aligning with the holistic
approach to care. Therefore, investigating the efficacy of Dhanyaka Kalka with Anupana of Sharkara mixed Tandulodaka in Garbhini Chardi holds promise for providing a safe, effective, and
culturally sensitive treatment option for pregnant women.
• By conducting a comparative clinical
study, we aim to scientifically evaluate the effectiveness of this Ayurvedic
formulation in reducing vomiting frequency and severity, improving maternal
quality of life, and ensuring fetal well-being. This research seeks to bridge the gap
between traditional Ayurvedic knowledge and modern evidence-based medicine,
paving the way for integrative approaches to prenatal care and enhancing
outcomes for pregnant women worldwide.
|