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CTRI Number  CTRI/2025/01/078969 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
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   Effect of Sharbat Anar Sheerin in comparision with Ferrous Ascorbate in iron deficiency anemia during pregnancy-A randomised controlled trial 
Scientific Title of Study   Effect of Sharbat Anar Sheerin versus Ferrous Ascorbate in iron deficiency anemia during pregnancy- A randomized controlled trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zoha Zaya 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  OPD no 32 Dept.Ilmul Qabalat wa Amraze Niswan National Institute of Unani Medicine, Kottegepalya, Magadi main road,Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9752145434  
Fax    
Email  zayazoha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ismath Shameem 
Designation  Professor and HoD 
Affiliation  National Institute of Unani Medicine 
Address  OPD no 32 Dept. Ilmul Qabalat wa Amraze Niswan National Institute of Unani Medicine, Kottegepalya, Magadi main road,Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9449977008  
Fax    
Email  dr.ismaths@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Ismath Shameem 
Designation  Professor and HoD 
Affiliation  National Institute of Unani Medicine 
Address  OPD no 32 Dept Ilmul Qabalat wa Amraze Niswan National Institute of Unani Medicine, Kottegepalya, Magadi main road,Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9449977008  
Fax    
Email  dr.ismaths@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine kottegepalya magadi main road Bangalore ,Karnataka 560091 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine ,Kottegepalya ,Magadi ,main road ,Bangalore,560091 
Type of Sponsor  Research institution and hospital 
 
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 
DrZoha Zaya  National Institute of Unani Medicine  OPD No 32 Ilmul Qabalat wa Amraze Niswan National Institute of Unani Medicine Kottegepalya Magadi main road,Bangalore
Bangalore
KARNATAKA 
09752145434

zayazoha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Unani Medicine ,Bangalore,Communication of Decision of Ethics committee (IEC) of Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D508||Other iron deficiency anemias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sharbat Anar sheerin   25ml sharbat will be administered orally twice daily after meals for 8 weeks.  
Comparator Agent  Tablet Ferrous Ascorbate 100mg   Tablet Ferrous Ascorbate 100mg will be administered orally once daily after meal for 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant women in the age group of 18 to 40 years, having singleton pregnancy between 13 to 26 weeks of gestation with mild to moderate anemia (Hb 7-10.9g/dl) with or without symptoms of dyspnoea, oedema, weakness, anorexia and fatigue.

 
 
ExclusionCriteria 
Details  Pregnant women with systemic illnesses e.g HTN (systolic BP ≥140mmHg and diastolic BP ≥90mmHg),DM (FBS≥95mg/dl),TD, multiple gestation and anemia due to other causes like hemolytic anemia and hemorrhagic anemia . 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Hb%, Peripheral smear and Hematocrit value  baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
No secondary outcome  Not Applicable 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   31/01/2025 
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 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  

Iron deficiency anemia is the most common cause of anemia during pregnancy. (WHO) defines anemia in pregnancy as hemoglobin (Hb <11 g/dL), or hematocrit (Hct <33%), at any time during the pregnancy.1 Anemia affects 20% of pregnant women; with iron, folic acid, or combined deficiencies being the most common causes. Based on WHO’s statistics, prevalence of anemia in pregnancy accounts for about 14% in developed and 51%in developing countries; India contributes to 65-75% of the cases.2 Risk factors for iron deficiency anemia (IDA) among pregnant women include a diet lacking adequate iron consumption, obesity, increased parity, low socioeconomic status, low educational attainment, ethnic minority etc.Pregnancy-related factors that worsens preexisting anemia in Indian women include increased iron and nutritional needs, excessive blood loss during labor, infections during the prenatal and postnatal phases and rapid successive pregnancy.3 In pregnant women, IDA is associated with an increased risk of preterm labour, low neonatal weight and perinatal complications. Severe IDA is also associated with increased perinatal and maternal mortality due to lower tolerance to excessive blood loss during delivery and increased risk of infections. Iron deficiency may hinder defective myelination in infants, so that the resulting anemia produces long-lasting defects in mental development and performance that may further impair the child learning capacity. Therefore, every case of anemia should be treated in pregnancy.4Therapy for IDA includes dietary modification, oral iron supplementation, intravenous iron and blood transfusion. WHO suggests 30-60 mg per day iron supplementation for all pregnant women .1 The main issue with oral iron therapy is compliance due to associated gastrointestinal side effects like bloating, diarrhea , heartburn, nausea, constipation, and dark stools.5 Intramuscular iron should be avoided as it is painful, requires multiple injections, stains the buttock, and is associated with gluteal sarcoma .Parentral iron is expensive and is associated with serious adverse effects (SAEs), including anaphylaxis and infusion minor reactions.1,6 Thus, the necessity for an alternative medical system emerges to minimise IDA’s complications and recurrence while providing minimal adverse effects and most economical treatment. Unani system of medicine provides cost effective and easily available medications which are relatively free from side effects. Hence, A randomized standard controlled clinical study is contemplated to evaluate and validate the therapeutic effect of Sharbat Anar Sheerin 7,8(Punica granatum Linn) on scientific parameters in IDA during pregnancy.

 
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