| CTRI Number |
CTRI/2018/05/013602 [Registered on: 02/05/2018] Trial Registered Prospectively |
| Last Modified On: |
23/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Interventional Orally does] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Managment of Emesis Gravidarum in Ayurveda |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of subidhabala khand in garbhini chardi w.s.r.to emesis gravidarum |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansa Devi |
| Designation |
Pg Scholar |
| Affiliation |
Parul institute of Ayurved |
| Address |
Opd no . 104 , Departmant of Stri roga and Prasuti Tantra, Parul Institute of Ayurved, Parul university, Limda, Vadodra, Gujarat, 391760, India
Vadodara
GUJARAT
391760
India |
| Phone |
9412338866 |
| Fax |
|
| Email |
Mansa.pit2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr mansi modi |
| Designation |
Asso Professor & HOD |
| Affiliation |
Parul institute of Ayurved |
| Address |
Opd no 104 Departmant of Stri roga and Prasuti Tantra, Parul Institute of Ayurved, Parul university, Limda, Vadodra, Gujarat, 391760, India
Vadodara
GUJARAT
391760
India |
| Phone |
9979883317 |
| Fax |
|
| Email |
mansi.modi1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr mansi modi |
| Designation |
Asso Professor & HOD |
| Affiliation |
Parul institute of Ayurved |
| Address |
Opd no 104 Departmant of Stri roga and Prasuti Tantra, Parul Institute of Ayurved, Parul university, Limda, Vadodra, Gujarat, 391760, India
Vadodara
GUJARAT
391760
India |
| Phone |
9979883317 |
| Fax |
|
| Email |
mansi.1modi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of Ayurveda and hospital , Limda , Vadodara |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved and Hospital |
| Address |
Parul Institute of Ayurved, Parul university, Limda, Vadodra, Gujarat, 391760, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Mansa Devi |
Parul Institute of Ayurved and Hospital |
Parul Institute of Ayurved, Parul university, Limda, Vadodra, Gujarat, 391760, India
Vadodara
GUJARAT |
9412338866
Mansa.pit2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Emesis Gravidarum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Subidhabala khand |
Bilwa, Dhanyak, Bala, Shunti, laja, Munga, Sarkara, each are used in equal quantity |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patient diagnosed as Garbhini chardi (emisis gravidarum) in first Trimester of Pregnancy.
Both Primi and Multi gravida. |
|
| ExclusionCriteria |
| Details |
Patients in whom chardi in second and Third Trimester, hyper Emesis gravidorum, twin Pregnancy and Vesicular mol, and Due to other systemic disorders like Peptic Ulcer, Appendicitis etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vomiting
Nausea
Anorexia |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decereasing Vomiting along Nausea and Anorexia |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypothesis :- Subidhabala khand has effective on Garbhini chardi |