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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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