| CTRI Number |
CTRI/2024/07/071428 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Sharbat Maweez in iron deficiency anemia |
|
Scientific Title of Study
|
Efficacy of Sharbat Maweez in the management of soo ul qiniya bawajahe qillat e faulad (Iron deficiency anemia) an open randomised standard control 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 |
Dr Sabeeh |
| Designation |
Post Graduate Scholar |
| Affiliation |
State Unani Medical College and HAHRDM Hospital |
| Address |
State Unani Medical College and Hospital, Department of Ilmul Atfal, OPD no. 2, Himmatganj Prayagraj UP
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9140531378 |
| Fax |
|
| Email |
sabeehsalam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Sohail |
| Designation |
Assistant Professor, HOD In Charge Department of Ilmul Atfal |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
State Unani Medical College and Hospital, Department of Ilmul Atfal, OPD no 2, Himmatganj Prayagraj U.P.
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9911799440 |
| Fax |
|
| Email |
shlt869@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Sohail |
| Designation |
Assistant Professor, HOD In Charge Department of Ilmul Atfal |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
State Unani Medical College and Hospital, Department of Ilmul Atfal, OPD no.2, Himmatganj Prayagraj UP
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9911799440 |
| Fax |
|
| Email |
shlt869@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital, Himmatganj, Prayagraj,UP, India-211016 |
|
|
Primary Sponsor
|
| Name |
Dr Sabeeh |
| Address |
Department of Ilmul Atfal, OPD no. 2, State Unani Medical College and Hospital, Himmatganj Prayagraj UP 211016 |
| Type of Sponsor |
Other [(Self)] |
|
|
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 |
| Dr Sabeeh |
State Unani Medical College and Hospital |
OPD no 2,Department of Ilmul Atfal, Ground Floor, State Unani Medical College and Hospital, Himmatganj Prayagraj UP 211016
Allahabad
UTTAR PRADESH |
9140531378
sabeehsalam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ferrous Sulphate |
Ferrous Suplhate daily at the dose of 3mg/kg/day for 8 weeks |
| Intervention |
Sharbat Maweez |
sharbat maweez every day according to the age for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Hb less than 12g/dl
Patients suffering from worm infestation shall be de wormed first after that they
will be included in the study
|
|
| ExclusionCriteria |
| Details |
Severe anemia Hb less than 6 gm %
Indication for blood transfusion
Patient with any other type of anemia Thalassemia Sickle cell anemia
Patients suffering from internal and external active bleeding chronic or critical
illness, any systemic disease e.g. Valvular heart disease Congenital heart
disease Renal failure Malignancy Pulmonary Tuberculosis
Mental impairment
Patients who fail to follow up
Patients who fail to give consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hb% PCV MCH MCHC |
Improvement in Hb% PCV MCH MCHC assess at every 14th day for 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in decrease appetite weakness palpitation dyspnea on exertion |
Improvement in decrease appetite weakness palpitation dyspnea on exertion assess at every 14th day for 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
03/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Anemia is the abnormal reduction in the number of circulating RBC, the quantity of hemoglobin, and the volume of packed red cells in a given unit of blood resulting in lower ability for the blood to carry oxygen to body tissues. Iron deficiency is the commonest cause of anemia, especially in developing countries where a sizeable percentage of population is anaemic. Iron is essential for multiple metabolic processes including oxygen transport, DNA synthesis and electron transport. Iron deficiency can also result in diminished growth and learning. According to National Family Health Survey NFHS4 data, the incidence of anemia in urban children is 55.9%, rural is 59.4% and overall is 58.4%. According to WHO definition of anemia, children of 6 months to 5 years with hemoglobin <11 gm/dl, 5 years to 11 years with hemoglobin <11.5gm/dl, 12 years to 14 years with hemoglobin <12gm/dl,15years to 19 years girls with hemoglobin <12gm/dl and boys with hemoglobin <13gm/dl are considered anemic. Pregnant females with hemoglobin <11gm/dl, non pregnant females with hemoglobin <12gm/dl and adult males having hemoglobin <13gm/dl are considered anemic. Iron need is maximum in the period of infancy and childhood. Iron deficiency at this age can result in neurodevelopmental and cognitive deficits which may not be reversible. Iron deficiency also makes the children susceptible for infection, seizures, breath holding spells in children and exacerbations of restless legs syndrome in adults. Iron deficiency can arise either due to inadequate intake, poor bio-availability of dietary iron. Anemic patients particularly children are at high risk of long term impairment of mental or motor development, low IQ level, lack of concentration and decreased physical activity. Iron tablets and syrups have certain side effects such as abdominal cramping, nausea, constipation, dark and hard stool. Now attention is focused on herbal drugs due to their variable role in anemia with no or negligible side effects and cost effectiveness. Therefore the search for efficient and safe medications for the treatment of anemia is of utmost importance. |