| CTRI Number |
CTRI/2025/02/081365 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| 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
|
study on anemia with two different drugs (itrifal fauladi and majoon khabsul hadeed) |
|
Scientific Title of Study
|
A comprative evaluation of itrifal fauladi with majoon khabsul hadeed in the management of su-al-qinya (iron deficiency anemia): An open label randomized clinical trial. |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KM SUCHITA |
| Designation |
PG Scholar |
| Affiliation |
Govt. Tibbi College And Hospital Patna |
| Address |
Govt. Tibbi College And Hospital Patna
Department of moalajat
room no.29
Patna
BIHAR
800003
India |
| Phone |
9953893412 |
| Fax |
|
| Email |
chaudharisuchita51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Najibur Rahman |
| Designation |
Associate professor cum HoD |
| Affiliation |
Govt. Tibbi. College And Hospital Patna |
| Address |
Govt. Tibbi. College And Hospital Patna
Department of moalajat
Room no.29
Patna
BIHAR
800003
India |
| Phone |
9122332101 |
| Fax |
|
| Email |
drmdnajibur.rahman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Razi Ahmad |
| Designation |
Associate Professor |
| Affiliation |
Govt. Tibbi. College And Hospital |
| Address |
Govt. Tibbi. College And Hospital Patna
Department of moalajat
Room no.29
Patna
BIHAR
800003
India |
| Phone |
7909035622 |
| Fax |
|
| Email |
dr.razi.ahmed91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Tibbi College and Hospital kadamkuan patna pin code 800003
india |
|
|
Primary Sponsor
|
| Name |
Govt Tibbi College And Hospital Patna |
| Address |
Govt. Tibbi. College And Hospital kadamkuan patna pin code 800003
india |
| Type of Sponsor |
Government medical college |
|
|
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 |
| KM SUCHITA |
Govt. Tibbi College and Hospital Patna |
Govt. Tibbi. Hospital kadamkuan patna
OPD NO. 29
Patna
BIHAR |
9953893412
chaudharisuchita51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt. Tibbi College and Hospital |
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 |
Control Drug: Majoon khabsul hadeed |
05 gm OD for 60 days orally after meal with normal water
|
| Intervention |
Itrifal Fauladi |
7 gm OD for 60 days orally after meal with normal water |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. patient having hemoglobin between 7gm/dl to 12gm/dl.
2. MCV less than 80fl
3. MCH less than 26pg
4. MCHC less than 31gm/dl
5. Serum ferratin less than 10mcg
6. Patient suffering from Microcytic hypochromic anaemia on Blood Peripheral smear/ |
|
| ExclusionCriteria |
| Details |
1) Patients not willing to sign the consent form.
2) Patient below the age of 18 years and above the age of 65 years.
3) Pregnant and lactating women.
4) Patient already taking treatment for anemia.
5) Patients suffering from malignancy, Hypertension, Diabetes mellitus.
6) Patients with any bleeding history e.g., Abnormal uterine bleeding, piles/rectal bleeding, haemoptysis and hematemesis etc.
7) Patients with chronic renal failure.
8) Patients with chronic liver disease.
9) Patients suffering from thalassemia /sickle cell disease and any other haemolytic disorders.
10) Patients taking blood thinners or any other drug which causes haemolysis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Haemoglobin
2. Peripheral blood smear
3. Serum ferritin
|
at baseline, 30 days, and 60 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pallor.
2. Fatigue.
3. Dyspnoea.
4. Giddiness.
5. Anorexia
|
at baseline, 30 days, and 60 days |
|
|
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)
|
20/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
patient fulfilling the inclusion criteria will be inrolled in the study after obtained the informed consent. A detailed history subjective and objective parameter will be evaluated at each visit. All subjective and objective parameter will be assessed. Treatment protocol explained well to the patient will be instructed not take any other medication during trial. treatment will be given for 60 days in semisolid compound form. and symptoms will be assessed on each visit followed by post trial investigation. All finding will be recorded. |