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CTRI Number  CTRI/2023/10/059046 [Registered on: 23/10/2023] Trial Registered Prospectively
Last Modified On: 19/10/2023
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 to Evaluate Safety and Efficacy of a Unani Formulation in Anaemia 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of a Herbomineral Unani Formulation Itrifal Fauladi in the Management of Faqr al-Dam ( Anaemia) 
Trial Acronym  N/A 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kahkashan Bano 
Designation  P G Scholar 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department Of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8318869511  
Fax    
Email  bano.kahkashan92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Arzeena Jabeen 
Designation  Professor  
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department Of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  9032519286  
Fax    
Email  aarzu763@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kahkashan Bano 
Designation  P G Scholar 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department Of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8318869511  
Fax    
Email  bano.kahkashan92@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute Of Unani Medicine For Skin Disorders 
 
Primary Sponsor  
Name  National Research Institute of Unani Medicine for Skin Disorders. 
Address  A.G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kahkashan Bano  National Research Institute of Unani Medicine for Skin Disorders.  OPD & IPD of Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders. A.g Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038
Hyderabad
TELANGANA 		 8318869511

bano.kahkashan92@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D539||Nutritional anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ferrous Sulphate  Ferrous Sulphate Dosage Form: Tablet Dose :200mg once a day Mode of Administration: Oral Duration of Therapy: 84 Days 
Intervention  Itrifal Fauladi  Dosage form:Itrifal (Semisolid) Dose: 7gm once daily Mode of administration: Oral Composition of Itrifal Fauladi : 1.Amla (Emblic officinalis) 2.Namak-e-Sang(Rock salt) 3.Filfil-e-Daraz(Piper longum) 4.Post-e-Haleela(Terminalia chebula Bark) 5.Kushta-e-Faulad 6.Satawar(Asparagus racemosus) 7.Asl-us-Soos(Glycyrrhiza glabra) 8.Maweez Munaqqa (Vitis vinifera) 9.Raughan-e-Zard(Ghee) Qs 10.Nabat Safaid (Sugar) 11.Asal ( Apis mellifera) Duration of Therapy: 84 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The following participants will be included in the study:
1 Participants in the age group of 18-60 years of either gender having any of
the following signs and symptoms.
Pallor
Weakness and Fatigue
Dyspnea
Palpitation
Anorexia
Angular Stomatitis and Glossitis
Oedema
Koilonychia (Spoon Shaped Nail)
Dizziness
Fainting

2 Heamoglobin:
Male, >8.0 gm% & <13gm%
Female, >7.0 gm% & < 12.0gm% 
 
ExclusionCriteria 
Details  The following patients will be excluded from the study:
1 Participants aged <18years and >60years of age.
2 Participants with haemoglobin < 8.0 & >13 gm% in Males where as <7.0
& >12.0 gm% in Female.
3 History of acute blood loss, chronic diseases requiring long term
treatment.
4 Pregnant and lactating women were excluded.
5 Known case of significant Pulmonary/ Cardiovascular/ Hepatorenal
Dysfunction/ Malignancy/ HIV Infection /AIDS etc .
6 Known allergy to herbal drugs.
7 Those who are unwilling to come for regular follow up for the entire
duration of the study.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Hb(gm/dl) at 12 weeks from base line  84 days 
 
Secondary Outcome  
Outcome  TimePoints 
1) Improvement in signs & symptoms
2) Change in Reticulocyte Count, S.Ferritin level, RBC Count, PCV, MCV,
MCH,MCHC. 		 84 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/ Phase 3 
Date of First Enrollment (India)   30/10/2023 
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 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   According to WHO Anaemia is a condition in which the number of red cells or the haemoglobin concentration within them is lower than normal. It is recommended that anaemia should be considered to exist in adult whose haemoglobin levels are lower than 13gm/dl (men) or 12gm/dl (women).Around 30% of the world’s population is anaemic and half of these are believed to have Iron Deficiency Anaemia. Globally, it is estimated that 40% of all children aged 6–59 months, 37% of pregnant women and 30% of women 15–49 years of age are affected by anaemia. The conventional medicine has various side effects such as epigastric pain ,heartburn ,nausea ,vomiting, bloating staining of the teeth, metallic taste, colic, usually constipation and some times diarrhoea.  So we select a classical Unani formulation to evaluate the safety and efficacy of the formulation.

 This Randomized, Active Controlled, Parallel Group, Open Label, Clinical Study is planned to evaluate the safety and efficacy of the herbomineral Unani formulation  Itrifal Fauladi in the management of  Faqr al-Dam .Participants fulfilling Inclusion and Exclusion criteria will receive either Test or Control drug as per Randomization. In Test drug participants will start with Itrifal Fauladi  7gm  daily for 12 weeks. In Control drug participants will start with Ferrous Sulphate 200 mg/ day once for 12 weeks. Baseline and last follow up laboratory investigation will be done. Duration of study is 84 days. 

 
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