| CTRI Number |
CTRI/2025/02/079999 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Sharbat Tamar hindi in Nausea and Vomiting during pregnancy |
|
Scientific Title of Study
|
Effect of Sharbat Tamar hindi in Nausea and
Vomiting during Pregnancy: A pre and post interventional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vandana Bodana |
| Designation |
PG Scholar |
| Affiliation |
National Institude of Unani Medicine |
| Address |
OPD 32, Department of Ilmul Qabalat wa Amraze Niswan, National Institude of Unani Medicine Kottigepallya Magadi main road Banglore
Bangalore
KARNATAKA
560091
India |
| Phone |
8602985832 |
| Fax |
|
| Email |
vandanabodana34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ismath Shameem |
| Designation |
Professor |
| Affiliation |
National Institude of Unani Medicine |
| Address |
OPD 32, Department of Ilmul Qabalat wa Amraze Niswan, National Institude of Unani Medicine Kottigepallya Magadi main road Banglore
Bangalore
KARNATAKA
560091
India |
| Phone |
9449977008 |
| Fax |
|
| Email |
dr.ismaths@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ismath Shameem |
| Designation |
Professor |
| Affiliation |
National Institude of Unani Medicine |
| Address |
OPD 32, Department of Ilmul Qabalat wa Amraze Niswan, National Institude of Unani Medicine Kottigepallya Magadi main road Banglore
KARNATAKA
560091
India |
| Phone |
9449977008 |
| Fax |
|
| Email |
dr.ismaths@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine, kottigepalya, Magadi main road, Bangalore Karnataka, India, 560091 |
|
|
Primary Sponsor
|
| Name |
National Institude Of Unani Medicine |
| Address |
National Institute Of Unani Medicine, kottigepalya, Magadi main road, Bangalore Karnataka, India, 560091 |
| 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 |
| DrVandana bodana |
National Institute Of Unani Medicine |
OPD 32, Department of Ilmul Qabalat Wa Amraz e Niswan
Bangalore
KARNATAKA |
8602985832
vandanabodana34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for biomedical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O219||Vomiting of pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Sharbat Tamar hindi |
Sharbat will be prepared as per the standard method mentioned in classical Unani
pharmacopea.25 ml sharbat will be administered orally with water twice, half an
hour before food for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women in age group of 18-35 years with singleton fetus between 6-10 weeks of gestation having nausea and vomiting of mild to moderate (3-12) PUQE score |
|
| ExclusionCriteria |
| Details |
Patient with PUQE Score more than 3
History of peptic ulcer gastroenteritis pancreatitis cholecystitis appendicitis renal stone
systemic diseases like HTN GDM thyroid dysfunction
Multiple pregnancy abortion ectopic pregnancy molar pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in PUQE 24 score |
At baseline, 2 weeks, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2025 |
| 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 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
|
Nausea and vomiting in pregnancy (NVP) is one of the most common problem during
pregnancy with an incidence of 70-85%.1 It occur at any time of the day, in 80% of
cases nausea and vomiting occur during the day and in 3% it happens in afternoon and
evening. During pregnancy, women normally experience nausea and vomiting known
as morning sickness.2 NVP begin in first trimester at about 6-8 weeks, peaking at about
9 weeks and subside at about 12 weeks of gestation, and it persist in some cases even
after 20 weeks of gestation.3
NVP causes discomfort and disrupt the woman’s daily life in mild cases, while in
severe cases, it endanger the health of both mother and fetus.2 The severe vomiting in
pregnancy is known as hyperemesis gravidarum, which often requires hospitalization
due to weight loss, poor nutrition, and dehyderation.4 NVP causes inadequate food
intake resulting in malnutrition, reduced energy and fatigue, electrolyte imbalance, weakness and dehydration.2 It is accompanied by an increased risk of maternal stress, anxiety, depression, low quality of life and reduction in maternal physical and social
function.5
In conventional medicine, the treatment is mainly symptomatic which includes dietary
changes, nutritional therapy, oral pharmacological treatment and hospitalization (if
severe) with intravenous fluid replacement. Vitamin B6 is used as the first-line of
treatment for NVP; however, current studies support the use of metoclopramide and
antihistamines such as doxylamine and ondansetron. In early pregnancy, these drugs
are avoided due to their potential teratogenic effects. Hence, there is an increasing
tendency towards the use of alternate medicine especially the herbal medicine to fulfil
this demand.1
Various formulations are available in USM such as Sharbat-i-turanj, Sharbat-i-leemu, Sharbat-i-ghaura, Sharbat-i-zanjabeel, Jawarish-i-oodtursh, Murraba-i-amla etc,6,7
which can be used in the management of NVP, but scientific studies are lacking.
6.2
6.3
7.
Therefore, it has been decided to conduct a clinical trial to evaluate the effect of
Sharbat Tamar hindi 8
in pregnancy induced nausea and vomiting |