| CTRI Number |
CTRI/2025/10/096507 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| 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
|
Clinical Study on Iron Deficiency |
|
Scientific Title of Study
|
A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, ACTIVE CONTROLLED, CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF HABB I KHABATH AL HADID COMPARED WITH FERROUS SULPHATE IN THE MANAGEMENT OF FAQR AL DAM (IRON DEFICIENCY ANAEMIA) |
| 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 Shaikh Reshma Bano Mohammad Haneef |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders
AG Colony road, opposite to ESI hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
7972817787 |
| Fax |
|
| Email |
reshshaikh313@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
prof Qamar uddin |
| Designation |
Professor |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
epartment of Moalajat, National Research Institute of Unani Medicine for Skin Disorders
AG Colony road, opposite to ESI hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
qamaruddindr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaikh Reshma Bano Mohammad Haneef |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
epartment of Moalajat, National Research Institute of Unani Medicine for Skin Disorders
AG Colony road, opposite to ESI hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
7972817787 |
| Fax |
|
| Email |
reshshaikh313@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute Of Unani Medicine For Skin Disorder, Hyderabad |
|
|
Primary Sponsor
|
| Name |
NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS HYDERABAD |
| Address |
AG COLONY ROAD,OPPOSITE TO ESI HOSPITAL,ERRAGADDA,HYDERABAD 500038 |
| 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 |
| Dr Shaikh Reshma Bano Mohammad Haneef |
National Research Institute of Unani Medicine And Skin Disorder |
Department of Moalajat
AG Colony Road Erragadda, Opossite to ESI hospital
Hyderabad
TELANGANA |
7972817787
reshshaikh313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NRIUMSD, HYDERABAD |
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 |
200 mg once a day for 8 weeks |
| Intervention |
habbe Khabsul Hadid |
Composition:
Khabs-ul-Hadeed (Iron oxid) 380gm
Habb-ul Rashaad (Lepidium sativum L) 80 gm
Tukhm-e-Gandana 9Allium ascalonicum L) 70 gm
Tukhm-e-Jirjeer (Eruca Sativa Mill.) 70 gm
Tukhm-e-karafs (Apium Graveolens L.) 70 gm
Tukhm-e-Gazar (Daucus carota L.) 70 gm
Tukhm-e-Turb (Raphanus Sativa L.) 70 gm
Tukhm-e-Hulba (Trigonella Foenum-Graecum L) 70 gm
Tukhm-e-Payaz (Allium Cepa L.) 70 gm
Heel Khurd (Elettaria Cardamomum Maton)70 gm
Dosage: 1 habb (630mg) twice daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants of any gender in the age group of 18-60 years
Participants with Iron Deficiency Anaemia (IDA) defined for this study as moderate anaemia with
Haemoglobin (Hb) levels between 8 g/dL and 10.9 g/dL and
Serum Ferritin level less than 15 µg/L
Participants having any of the following signs and symptoms.
Pallor of Skin and Mucous Membranes
Easy Fatigability
Reduced Work or Exercise Capacity
Dyspnoea on Exertion
Palpitations
Ability to understand and give informed consent for participation.
Willing to come for follow up visit as per protocol requirement. |
|
| ExclusionCriteria |
| Details |
Participants aged less than 18 year and more than 60 years of age.
Participants with Hemoglobin less than 8 g/dL and more than 10.9 g/dL
Pregnant and Lactating Women
Known Case Of Diabetes mellitus
History of Acute Blood Loss
Known Cases of Cardiovascular/ Hepatic/ Renal Disorders or chronic diseases requiring long-term treatment
Known Hypersensitivity to the study drug or any of its ingredients |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Haemoglobin level at 56th Day from baseline |
2nd and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Serum Ferritin level at 56th day from baseline
Changes in Hematological Parameters (RBC,MCV,MCH,MCHC)at 56th day from baseline
Changes in Peripheral Blood Smears at 56th day from baseline
Relief in Signs & Symptoms – Easy Fatigability, Reduced Work or Exercise Capacity, Dyspnoea on Exertion, Palpitation, Pallor at 56th day from baseline
Evaluation of Safety by:
a.Monitoring Adverse Events (AEs)
b.Changes in Laboratory Parameters (performed at baseline and at week 8) |
2nd and 4th week |
|
|
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 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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
|
Anaemia is condition in which the number of red blood cells or the hemoglobin concentration within them is lower than normal The WHO recommondes that anaemia should be consider to exist in adults whose hemoglobin level are lower than 13 gm/dl in males and 12 gm /dl in females.The several iron containing medication are utilized in modern medicine but oral iron therapy is frequently associated with adverse effect particularly involving GI tract that is constipation diarrhea abdominal bloationg abdominal discomfort and detal staining. Given the current context it is essential to assess effectiveness of Unani medicine in treating iron deficiency anaemia as they offer safe and cost effective alternative. for this purposed study Habb e Khabsul hadid has been selected. The aim of the study to generate safety and efficacy data in the managment of iron deficiency anaemia based on modern scientific parameters. |