| CTRI Number |
CTRI/2026/03/105796 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY TO EVALUATE THE EFFECTIVENESS OF CHHARDIHAR KASHAY IN MANAGING VOMITING DURING PREGNANCY (EMESIS GRAVIDARUM) |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHHARDIHAR KASHAY IN THE MANAGEMENT OF GARBHINI CHHARDI (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 Shital Parshuram Tambare |
| Designation |
PG scholar Streeroga and Prasutitantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyalay |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Streeroga and Prasutitantra OPD No18
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8698875268 |
| Fax |
|
| Email |
shitaltambare123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Anandrao Havale |
| Designation |
Associate Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalay |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Streeroga and Prasutitantra OPD No18
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9822538957 |
| Fax |
|
| Email |
amolhavale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital Parshuram Tambare |
| Designation |
PG scholar Streeroga and Prasutitantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyalay |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Streeroga and Prasutitantra OPD No18
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9822538957 |
| Fax |
|
| Email |
shitaltambare123@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar India 431011 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyalaya And Rugnalaya |
| Address |
Kanchanwadi Chhatrapati Sambhajinagar India 431011 |
| 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 Shital Parshuram Tambare |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA |
8698875268
shitaltambare123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Institution Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chardihar kashay, Reference: Sahasrayoga , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: Baseline 10th day 20th day 30th day | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Lajakapitthadi Yog , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Baseline 10th 20th 30th |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All patients diagnosed with 6th to 14th weeks of single live pregnancy with chhardi (primi and multi gravida ) irrespective of parity and religion
Married female patient between age of 21 to 35 years |
|
| ExclusionCriteria |
| Details |
Patients with second and third trimester
Garbhini with Hyperemesis Gravidarum
Pregnant women with vomiting due to other systemic diseases such as intestinal obstruction appendicitis cholecystitis hypertension jaundice etc
Known case of diabetes mellitus
Multiple pregnancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hrullas Chhardi Daurbalya Aruchi these symptoms reduces |
1month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare effect of chhardihar kashay and lajakapitthadi yog in the management of Garbhini Chhardi (Emesis Gravidarum)
To study Garbhini Chhardi according to Ayurveda
To study Emesis Gravidarum according to Modern Science |
1month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/03/2026 |
| 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="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
|
In Ayurvedic classics vomiting during pregnancy is described under the entity Garbhini Chhardi which is mentioned as Sadyograhita Garbha Lakshana in Ashtanga Sangraha and as Vyakta Garbha Lakshana in Charaka and Sushruta. Acharyas have explained that due to Garbha Vriddhi and Douhrida Avastha there is aggravation of Doshas leading to Agnimandya and Utklista Dosha state The vitiated Kapha and Pitta along with Avarodha of Vata cause Vilomagati of Udana and Vyana Vayu resulting in Chhardi Acharya Harita has included Chhardi among the eight Garbhopadravas emphasizing its clinical importance Garbhini Chhardi can be correlated with Emesis Gravidarum in modern obstetrics Nausea and vomiting are common during the first trimester and affect nearly 50–70% of pregnant women Though mild symptoms are physiological severe cases may lead to dehydration electrolyte imbalance weight loss nutritional deficiency metabolic disturbances and adverse fetal outcomes such as low birth weight and preterm labor Hence timely management is essential to protect both maternal and fetal health Modern management mainly depends on antiemetics and supportive therapy However prolonged use of certain medications during pregnancy may raise concerns regarding safety and side effects Therefore safe and effective Ayurvedic alternatives are needed. According to Sahasrayoga Chhardihar Kashay is indicated in Chhardi It contains Shunthi Bilwa and Laja which possess Deepana Pachana Kapha-Pitta Shamana and Vatanulomana properties These drugs are considered safe in pregnancy and help in correcting Agnimandya and controlling vomiting Considering this the present study is planned as a Randomized Controlled Clinical Trial to evaluate the efficacy of Chhardihar Kashay in the management of Garbhini Chhardi (Emesis Gravidarum) Diagnosed patients will be selected assessed before and after treatment and results will be analyzed statistically to draw a valid conclusion
|