| CTRI Number |
CTRI/2025/03/082641 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effect of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu in Garbhini Chardi/ Hyperemesis Gravidarum. |
|
Scientific Title of Study
|
A randomised open-labelled comparative clinical study to evaluate the efficacy of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu in the Management of Garbhini Chardi With special reference to Hyperemesis 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 Shivangi Sanghvi |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, UDayapura P.O, Bangalore-560082
Bangalore KARNATAKA 560082 India |
| Phone |
07208845890 |
| Fax |
|
| Email |
shivangisanghvi03@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shubha Ural |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, UDayapura P.O, Bangalore-560082
Bangalore KARNATAKA 560082 India |
| Phone |
9945600058 |
| Fax |
|
| Email |
Shubha.ural@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivangi Sanghvi |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, UDayapura P.O, Bangalore-560082
Bangalore KARNATAKA 560082 India |
| Phone |
07208845890 |
| Fax |
|
| Email |
shivangisanghvi03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research hospital 21st km OB Chudahalli, Kanakapura road, Bengaluru 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Shivangi Sanghvi |
| Address |
Sri Sri College of Ayurvedic Science and Research, Kanakapura Road, Udayapura P.O, 560082 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Sri College of Ayurvedic Science and Research |
Kanakapura road, Udayapura P.O, Bengaluru-560082 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivangi Sanghvi |
Sri Sri College of Ayurvedic Science and Research |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital Kanakapura Road, Udayapura P.O, Bangalore-560082 Bangalore KARNATAKA |
07208845890
shivangisanghvi03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O210||Mild hyperemesis gravidarum. Ayurveda Condition: GARBINYA VAMANAVYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shunthi Bilwa Kwatha with Yava Saktu, Reference: Yogaratnakara , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Jala ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilwadi Kwatha with Sharkara , Reference: SahasraYogam , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Based on ICD-11 Diagnosis Code JA60.0
1)Subjects between the age group of 18-45years.
2)Subjects with gestational age upto 22 weeks.
3)Both multigravida and primigravida.
4)Subjects with PUQE-24(Pregnancy Unique Quantification of Emesis)score upto 6.
5)Subjects with HELP(Hyper-Emesis Level Prediction)score upto 19.
6)Subjects with twin pregnancies and singleton.
7)Subjects diagnosed with symptoms of Garbhini Chardi.
8)Subjects with mild hypoglycemia, mild huponatremia, mild dehydration as per scale.
9)Subjects willing to sign the consent form. |
|
| ExclusionCriteria |
| Details |
1)Subject with PUQE score more than or equal to 7 to 15.
2)Subjects with HELP score more than or equal to 20 to 60.
3)Subjects with molar pregnancy and other systemic illness like cardiac diseases, TB, etc.
4)Subjects with Diabetes Mellitus.
5)Subjects with Psychiatric illness.
6)Subjects with moderate to severe hypoglycemia, moderate to severe hyponatremia, moderate to severe dehydration as per scale.
7)Subjects with vomiting in pregnancy due to medical causes, surgical causes, gynecological causes.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)The efficacy of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu will be established in the treatment of Garbhini Chardi with special reference to Hyperemesis Gravidarum.
2)Significant decrease in the symptoms of Garbhini Chardi with special reference to Hyperemesis Gravidarum assessed based on PUQE score, HELP score and other subjective and objective parameters. |
treatment period - 14 days
study duration - 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)To do literary review on Garbhini Chardi, Hyperemesis Gravidarum. |
1 year |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 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
|
Maternal physiology during
pregnancy phase is under continuous adaptation. Various physiological and
psychological changes take place during pregnancy. Garbhini Chardi is
one of the changes taking place in pregnancy and Ayurvedic classics have
mentioned Garbhini Chardi as one among the Vyakta Garbha Lakshsana[1,2,3].
Chardi is seen as a Vyakta Garbha Lakshana and is considered as
physiological condition when it is not associated with any deleterious effect
on mother and it becomes pathological condition, when it causes deleterious
effect on mother i.e.Hyperemesis Gravidarum. Hyperemesis Gravidarum is a
condition causing severe nausea and vomiting in early pregnancy which may
sometimes require hospitalization.[4]
According
to previous work done, the prevalence of Hyperemesis Gravidarum is 1.66% [5].
Proper consumption of nutrients is very essential for the growth of fetus and
well being of mother in early pregnancy, but due to intense nauseatic feeling, mother
cannot take sufficient quantity of nutrients and it may cause dehydration, tiredness,
weight loss which may affect the growth of fetus. In classics Acharyas have
mentioned that Garbhini should be
taken care like a pot filled with oil, as Garbhini Avastha is termed as
delicate state, the Aushadis which are been given to her must have Sukh
Sukumara properties[6]. Antiemetic drugs from contemporary
medicine lack to have nutritive, appetizer properties in it.
In Yogaratnakara,
individual drugs like Bilwa, Shunthi, Dhanayaka, Laja, Yava Saktu are
mentioned in Chikitsa of Garbhini Chardi[7]. In Kashyapa
Samhita, Mudga is mentioned in Chikitsa of Garbhini Chardi[8].
Antiemetic drugs from contemporary medicine lack to have nutritive, appetizer
properties in it. In Yogaratnakara, individual drugs like Bilwa,
Shunthi, Dhanayaka, Laja, Yava Saktu are mentioned in Chikitsa of Garbhini
Chardi[7]. In Kashyapa Samhita, Mudga is mentioned in Chikitsa
of Garbhini Chardi[8]. In Charaka Samhita, Bala is
mentioned as a Prajasthapana Gana.[9]
A single formulation
containing all these Dravyas is mentioned in Sahasrayogam and Yogaratnakara
as well as these reference are present in Quality Control and Standardisation of
Ayurvedic Medicine[10].
Bilwadi Kwatha with
Sharkara has properties like Deepana, Pachana, Rochana, Hridya, Chardihara,
Dahaprashamana, Tarpana, Kapha-Vatahara as well as it has vitamin B-complex
in it[11].
Shunthi Bilwa Kwatha with Yava
Saktu has properties like Ruchivardhaka, Agnideepaka, Amapachaka and
has carbohydrate which is easy for assimilation[12].
Since both the Yogas
are in Kwatha form, easy to prepare, safe in pregnancy, acts as Chardi-hara
and so this comparative study has been considered for the research work. • Null Hypothesis (H0): There is no significant difference between effect of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu in the management of Garbhini Chardi with special reference to Hyperemesis Gravidarum. • Alternative Hypothesis (H1): There is significant effect of Bilwadi Kwatha with Sharkara when compared to Shunthi Bilwa Kwatha with Yava Saktu in the management of Garbhini Chardi with special reference to Hyperemesis Gravidarum. • Alternative Hypothesis (H2): There is significant effect of Shunthi Bilwa Kwatha with Yava Saktu when compared to Bilwadi Kwatha with Sharkara in the management of Garbhini Chardi with special reference to Hyperemesis Gravidarum. |