| CTRI Number |
CTRI/2025/01/079186 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study on Iron Deficiency Anemia in women of reproductive age group |
|
Scientific Title of Study
|
Comparative effect of Barg Sahjana with Qurs Kushta Faulad in Iron Deficiency Anemia in women of Reproductive Age group A Randomized single blind controlled clinical 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 |
Tasneem Ali |
| Designation |
PG Scholar |
| Affiliation |
national institute of unani medicine |
| Address |
OPD No 29 national institute of unani medicine kottigepalya magadi main road bengaluru karnataka India 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
8109900937 |
| Fax |
|
| Email |
tasneemali96111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Wajeeha begum |
| Designation |
Professor |
| Affiliation |
national institute of unani medicine |
| Address |
OPD No 29 national institute of unani medicine kottigepalya magadi main road bengaluru 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9972550185 |
| Fax |
|
| Email |
drwajeehanium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Wajeeha begum |
| Designation |
Professor |
| Affiliation |
national institute of unani medicine |
| Address |
OPD No 29 national institute of unani medicine kottigepalya magadi main road bengaluru 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9972550185 |
| Fax |
|
| Email |
drwajeehanium@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of unani medicine kottigepalya magadi main road Banglore 560091 |
|
|
Primary Sponsor
|
| Name |
National institute of unani medicine |
| Address |
National institute of unani medicine kottigepalya magadi main road Banglore 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 |
| Tasneem Ali |
National institute of unani medicine |
OPD No 29 national institute of unani medicine kottigepalya magadi main road bengaluru 560091
Bangalore
KARNATAKA |
8109900937
tasneemali96111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E611||Iron deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Barg Sahjana |
Powder of Barg Sahjana 5gm BD will be administered orally with water after meals for 60 days. |
| Comparator Agent |
Qurs Kushta Faulad |
Qurs Kushta Faulad 2 Tablets BD orally with water after meals for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women of reproductive age between 18-45 years with mild (9.9-11.9 gm/dl) to moderate (7-9.9 gm/dl) iron deficiency anemia
|
|
| ExclusionCriteria |
| Details |
Study participant with
Severe anemia (Hb less than 7gm/dl).
Uncontrolled diabetes, hypertension,thyroid disease.
Heavy & irregular menses
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in objective parameters (Hb, S.Ferritin). |
at baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective parameters (pallor, breathlessness, and fatigue) |
0 day, 30 day, 60 day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/02/2025 |
| 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
|
Anemia or low concentration of haemoglobin (Hb) is a condition in which the number of red blood cells in the body is insufficient to meet physiological needs.Children, women of reproductive age, and pregnant women are at high risk of developing anemia.Iron deficiency is the primary cause of over half of all cases of anemia worldwide, making it a prevalent public health issue.The present study is undertaken to evaluate the effect of Sahjana (Moringa Oleifera lam.) The drug is of hot temperament contrasting to the temperament of the disease itself thus satisfying the concept of Ilaj-bil-zid efficiently, in comparison with Qurs Kushta Faulad,which is proven to increase Hb concentration in anemic patient as it acts as muwallid-e-dam.The effect of these will be assessed withthe subjective parameter that is pallor will be assessed with pallor scale.Fatiguewith facit scale, breathlessness with MRC scale will be compared concerning the findings of baseline on every follow-up. and objective parameters with Hb%, and S. Ferritin will be compared. |