| CTRI Number |
CTRI/2024/08/072939 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
18/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of nausea and vomiting in pregnancy with Sharbat Imli |
|
Scientific Title of Study
|
A Randomized Comparative Study of Sharbat Tamarhindi Versus Doxylamine Succinate in Emesis Gravidarum (Qay-al-haml) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PATHAN SANA AFROZ MD SHAFI |
| Designation |
PG Scholar |
| Affiliation |
Luqman Unani Medical College, Hospital and Research Centre, 12 Naubag, Vijaypur, Karnataka 586101 |
| Address |
Department of Ilmul Qabalat wa Amraze Niswan,
Luqman Unani Medical College, Hospital and
Research Centre, 12 Naubag, Vijaypur, Karnataka
586101
Bijapur KARNATAKA 586101 India |
| Phone |
8010408151 |
| Fax |
|
| Email |
sanakhantastic555@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR MOHD AQIL QUADRI |
| Designation |
Professor |
| Affiliation |
Luqman Unani Medical College Hospital and Research Center, Vijaypur, 586101 |
| Address |
Department of Ilmul Qabalat wa Amraze Niswan room no 2 floor no 1 Luqman Unani Medical College Hospital and Research Center Vijaypur, 586101 Karnataka India
Bijapur KARNATAKA 586101 India |
| Phone |
9849090182 |
| Fax |
|
| Email |
aqilquadri@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nikhat Kausar Inamdar |
| Designation |
Assistant Professor |
| Affiliation |
Luqman Unani Medical College Hospital and Research Center, Vijayapura, 586101 |
| Address |
Department of Ilmul Qabalat wa Amraze Niswan room no 2 floor no 1 Luqman Unani Medical College Hospital and Research Center Vijaypur, 586101 Karnataka India
Bijapur KARNATAKA 586101 India |
| Phone |
7019276469 |
| Fax |
|
| Email |
nikhatinamdar72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Luqman Unani Medical College Hospital and Research Center 12 Naubag,Vijaypur (bijapur) 586101 , Karnataka India |
|
|
Primary Sponsor
|
| Name |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Luqman Unani Medical College Hospital and
Research Center, Vijayapura, 586101 |
| 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 |
| DrPathan Sana |
luqman unani medical college hospital and research centre |
luqman unani medical college hospital and research centre Department of qabala wa niswan 2nd floor room no-1,12 naubagh vijayapura (bijapur) 586101 Bijapur KARNATAKA Bijapur KARNATAKA |
8010408151
sanakhantastic555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethical Committee (IEC) for Bio Medical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O210||Mild hyperemesis gravidarum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
doxylamine succinate |
Form Tablet
Dosage 10 mg bd Before food for 4 weeks.
Mode of administration oral administration |
| Intervention |
Sharbat tamarhindi |
Form Sharbat syrup Mode of administration orally Dosage 20 ml BD before food for 4 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Primigravida and Multigravida between the age of 18 to 35 years.
2.Gestational age of 6 to 14 week.
3.Mild to moderate NVP (3 to 12) score on the PUQE 24 scale.
4.No intake of anti-nauseant drug within at least 24 hours before visit. |
|
| ExclusionCriteria |
| Details |
1.Patients with hyperemesis gravidarum.
2.Patients in whom emesis seen in second and third trimester.
3.Patients with twin pregnancy and vesicular mole.
4.Vomiting caused due to other disorders like peptic ulcer, renal calculi, appendicitis, gastritis, malignancies.
5.Patients with systemic diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of nausea and vomiting by PUQE index. |
two follow ups weekly on 5 and 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of quality of life by NVPQOL questionnaire. |
two follow ups weekly on 5 and 6 week |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
29/08/2024 |
| 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="1" |
|
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
|
Emesis gravidarum also known as nausea and vomiting in pregnancy (NVP) It is a common condition with prevalence rates for nausea of 50–80% and for vomiting and retching of 50%.[1,2] It is a common reason for hospital attendance and admission in the pregnant woman.[3],[4] The beginning of emesis gravidarum is highly variable and is usually between the first and second missed menstrual cycle; it continues to 14 to 16 weeks of pregnancy and usually has the most severity from 7 to 9 weeks of pregnancy. In 50% of women, NVP resolves by the 14 weeks and in 90 percent of women by the 22 weeks.[5] NVP have significant adverse effect on the quality of women’s life.[4,6] NVP and their exact causes are still unknown so that hormonal, social, personal, psychological, racial and geographical factors are believed to be involved in their occurrence.[1,7] Treatment of nausea and vomiting also can be unsatisfactory because the available pharmacotherapy does not correct the fundamental underlying pathophysiological abnormalities.[8] Although there is medication available to treat NVP, some physicians and patients are reluctant to use these drugs due to reports of fetal malformations associated with antiemetic medications.[9] Ondansetron was quickly adopted as a first-line antiemetic for other causes of nausea and vomiting, including NVP.[10] A possible association between ondansetron use in the first trimester and cleft palate has been reported.[11] Concerns about teratogenicity in the first trimester and more subtle effects on foetal development have dramatically limited the use of orthodox medicine.[12] Pregnant women often use medicinal herbs in an effort to maintain good health and reduce the need for medical intervention.[5,13] The term used for emesis gravidarum in Unani literature is Qay’al-hawamil.[14] And to treat this condition, Unani scholars have been described several safe drugs which have been mentioned for oral administration in a form of single drug as well as compound formations, like some basic single drug are Zanjabeel (Ginger), Amla (Gooseberry), Anar (Pomegranate), Leemu (Lemoon) and Tamarhindi (tamarind).[15] And compounds are sikanjabeen-e-sada, jawarish-e-anarain, jawarish-e-tamarhindi, sharbat-e-anar, sharbat-e-lemu, shikanjabeen-e-tamarhindi and sharbat-e-tamarhindi.[14,16] Among of all Sharbat-e-tamarhindi is an important antiemetic drug used in management of emesis in pregnancy in unani medicine.[14,16,17] Various study shown that tamarhindi ‘Tamarindus Indica’ has antiemetic property which help to treat emesis gravidarum, astringent, anthelmintic, antiseptic, healing, antimicrobial and antiviral properties.[18] Considering this facts it has been decided to conduct the clinical trial to evaluate the safety and efficacy of Sharbat-e-tamarhindi in comparison with doxylamine succinate in patient with nausea and vomiting in pregnancy. |