| CTRI Number |
CTRI/2025/12/098926 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of VOMI - DEK sublingual film in comparison to doxylamine succinate with pyridoxine tablet in the management of vomiting due to pregnancy. |
|
Scientific Title of Study
|
A Study To Evaluate The Reproductive Toxicity And
Efficacy Of VOMI-DEK Film In The Management Of Garbhini
Chhardi w.s.r. To Emesis Gravidarum. |
| 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 HARITA CHOLERA |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
Room No 309 Department of Prasuti Tantra Evum Stri Roga Parul Institute of Ayurveda Parul University Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9409258389 |
| Fax |
|
| Email |
haricholera30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAULI VAISHNAV |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
Room no 309 Department of Prasuti Tantra EVum Stri Roga Parul Institute of Ayurveda Parul University Limda Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9589788336 |
| Fax |
|
| Email |
mauli.vaishnav36886@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR MAULI VAISHNAV |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
Room no 309 Department of Prasuti Tantra Evum Stri Roga Parul Institute of Ayurveda Parul University Limda Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9589788336 |
| Fax |
|
| Email |
mauli.vaishnav36886@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurveda Parul University Limda Waghodia Vadodara Gujarat - 391760 India |
|
|
Primary Sponsor
|
| Name |
PARUL INSTITUTE OF AYURVEDA PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT INDIA |
| Address |
Parul Institute of Ayurveda Department of Prasuti Tantra Evum Stri Roga 3rd Floor Parul University Limda Waghodia Vadodara Gujarat India - 391760 |
| 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 Harita Cholera |
Parul Ayurved Hospital |
OPD no 104 Department of Prasuti tantra evum stri roga, Parul Institute of Ayurveda, Parul University, Waghodia
Vadodara
GUJARAT |
9409258389
haricholera30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PARUL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O368||Maternal care for other specifiedfetal problems. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Doxylamine succinate with Pyridoxine | Tablet doxylamine succinate with pyridoxine
Dose - 1 tablet (20mg) each twice a day
Anupana - water
Duration - 15 days
Reference - ACOG - 2004 | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: VOMI - DEK FILM, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 278(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: WATER), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women of 1st trimester of pregnancy from 6 to 12 weeks,
Pregnant women with complaints of chhardi, hrullasa and aruchi,
Age 18-40 years,
Both primi and multi gravida. |
|
| ExclusionCriteria |
| Details |
Pregnant women not willing for trial,
Pregnant women with hyperemesis gravidarum,
Pregnant women with other systemic disorders like appendicitis, peptic ulcer,
IBS, hepatitis, diabetes, hypertension, VDRL +, etc.,
Pregnant women with molar pregnancy and ectopic pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find an alternative, safe and rapidly effective remedy for garbhini chhardi
w.s.r to emesis gravidarum.
To evaluate the efficacy of Vomi-DEK film in the management of garbhini chhardi w.s.r. to emesis gravidarum when compared to standard controlled drug. |
To find an alternative, safe and rapidly effective remedy and to evaluate the efficacy of Vomi-DEK film in the management of garbhini chhardi w.s.r. to emesis gravidarum when compared to standard controlled drug. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find an alternative, safe & rapidly effective remedy for garbhini chhardi
w.s.r to emesis gravidarum.
To evaluate the efficacy of Vomi-DEK film in the management of garbhini chhardi w.s.r. to emesis gravidarum when compared to standard controlled drug. |
To find an alternative, safe & rapidly effective remedy & to evaluate the efficacy of Vomi-DEK film in the management of garbhini chhardi w.s.r. to emesis gravidarum when compared to standard controlled drug. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
01/01/2026 |
| 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="3"
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 Chhardi is common complaint during the first trimester of pregnancy. It is worldwide common obstetrical problem seen in early pregnancy in about 70%- 80% of pregnant women. Garbhini avastha is termed as delicate state. It is important to treat this condition in initial stage and prevent complications. Slight vomiting is so common in early pregnancy (about 50%) that is considered as a symptom of pregnancy. It may occur at other times of the day. The usual onset for nausea and vomiting in pregnancy is between 4-9 weeks of gestation. NVP is common and usually begins at 6-8 weeks of gestation . Hence, there is need for an alternative, rational, safe and patent remedy. Oral thin films when placed on the tongue’s tip or floor, saliva quickly moistens the thin film, allowing for rapid hydration and subsequent disintegration to release the medication for oral mucosal absorption. The drug should dissolve easily in saliva and be highly moisture resistant. The drug should be able to permeate the oral mucosa. The quickly dissolving poly herbal oral thin films were prepared by any of the following suitable methods i.e. solvent casting method, semisolid casting method, hot melt extrusion, semi-dispersion extrusion method, roller method and drying of films. Main aim is to study the reproductive toxicity of the Vomi-DEK film and evaluate efficacy of the same in the management of garbhini chhardi w.s.r. to emesis gravidarum. The study will be carried out in such a way that firstly reproductive toxicity screening study will be done according to OECD (Organization for economic cooperation and development) guidelines 421 followed by a single blind randomized comparative clinical trial (Pilot study) will be carried out. Patients will be randomly divided into 2 groups out of which group A patients will be given trial drug and group B patients will be given standard controlled drug. Patients will be selected on the basis of inclusion and exclusion criteria. All assessment parameters and investigations will be taken into consideration. |