| 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
|
|
|
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
|
|
|
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. |