| CTRI Number |
CTRI/2025/02/080355 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| 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
|
Effect of kharjura mantha in garbhini chardi |
|
Scientific Title of Study
|
Randomised controlled clinical trial to evaluate the efficacy of kharjura mantha in the management of garbhini chardi with special reference 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 Urmila Sanjay Mote |
| Designation |
PG student |
| Affiliation |
Shree saptashrungi ayurvedic Mahavidyalaya and hospital |
| Address |
Department of Prasutitantra and streeroga Shree saptashrungi ayurvedic Mahavidyalaya and hospital Kamalnagar nagar Hirawadi panchavati nashik maharashtra
Kamal nagar ,hirawadi,panchavati,nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9022252196 |
| Fax |
|
| Email |
urmilamote1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urmila Sanjay Mote |
| Designation |
PG scholler |
| Affiliation |
Shree Saptashrungi ayurvedic Mahavidyalaya and hospital |
| Address |
Department of Prasutitantra and streeroga Shree Saptashrungi ayurvedic Mahavidyalaya and hospital nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9022252196 |
| Fax |
|
| Email |
urmilamote1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Suresh deshmukh |
| Designation |
Professor and guide |
| Affiliation |
Shree Saptashrungi ayurvedic Mahavidyalaya and hospital |
| Address |
OPD no. 3 department of striroga and prasutitantra shree saptashrungi ayurveda mahavidyalaya and hospital kamal nagar Panchavati Nashik Maharashtra India 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9403513983 |
| Fax |
|
| Email |
varshasdeshmukh15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi ayurvedic Mahavidyalaya and hospital nashik |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi ayurvedic Mahavidyalaya and hospital nashik |
| Address |
Department of Prasutitantra and streeroga Shree Saptashrungi ayurvedic Mahavidyalaya and hospital nashik |
| Type of Sponsor |
Other [Private ayurvedic collage] |
|
|
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 Urmila Sanjay Mote |
Shree Saptashrungi ayurvedic Mahavidyalaya and hospital nashik |
OPD no 3 department of Prasutitantra and streeroga Shree Saptashrungi ayurvedic Mahavidyalaya and hospital nashik
Nashik
MAHARASHTRA |
9022252196
urmilamote1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Shree Saptashrungi ayurvedic Mahavidyalaya and hospital nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E878||Other disorders of electrolyte andfluid balance, not elsewhere classified. Ayurveda Condition: GARBINIROGAH, (2) ICD-10 Condition:E348||Other specified endocrine disorders. Ayurveda Condition: GARBINYA VAMANAVYAPADAH, (3) ICD-10 Condition:E649||Sequelae of unspecified nutritional deficiency. Ayurveda Condition: GARBINIROGAH, (4) ICD-10 Condition:O219||Vomiting of pregnancy, unspecified. Ayurveda Condition: GARBINIROGAH, (5) ICD-10 Condition:O219||Vomiting of pregnancy, unspecified. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kharjur mantha, Reference: Bhavprakash nighantu Amrafaladivarga page no 586, Route: Oral, Dosage Form: Mantha, Dose: 20(ml), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Doxylamine succinate | Doxylamine succinate
40 mg BD |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
C/O hrullas chardi anannabhilasha Aruchi in garbhini with age of 21 to 35 years |
|
| ExclusionCriteria |
| Details |
Multiple pregnancy
Ectopic pregnancy
Severe anemia
Pregnancy with convulsive disorder
Hyperemesis gravidarum |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of garbhini chardi |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduce recurrence of garbhini chardi
Neutritional benifits to garbhini |
7 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
22/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/02/2025 |
| 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 - NO
|
|
Brief Summary
|
Emesis gravidarum the most common encountered clinical problems of early pregnancy occurs in approx 70% of all pregnancies. Garbhini chardi when seen as vyakta garbha lakshan there is no harm to mother as well as fetus . Ayurvedic classics have mentioned garbhini chardi as one of the garbhaupadrava which can be correlated with vomiting in pregnancy.However this natural phenomenon turns into nightmare when she suffers from hyperemesis gravidarum which may affect the mother as well as growing fetus. Vomiting excess causes discomfort and irritation to pregnant lady.if not treated early causes various complications. While explaining chikitsa in garbhini acharyas have mentioned that she should be given drugs which are easily palatable that is hrudya and one which is liked by her .kharjura mantha is vaatpittahar , ruchikar ,hrudya,balya,trushnahar ,and chardihar. Hence kharjura is selected for study. |