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CTRI Number  CTRI/2024/10/075271 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 10/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to compare the two Unani compound formulations in Iron Deficiency Anemia.  
Scientific Title of Study   Efficacy of Qurs kushta Khabsul Hadeed and Sharbat-e-Anar shirin in Iron Deficiency Anemia - A Randomized comparative single blind 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  KHAN SAIMA PARVEEN 
Designation  MD Scholar Unani 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi, India-110005

Central
DELHI
110005
India 
Phone  7977816298  
Fax    
Email  ksaimap05@gmail.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Nusrath Fathima 
Designation  Assistant professor 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Moalajat,Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh,New Delhi

New Delhi
DELHI
110005
India 
Phone  9131807199  
Fax    
Email  drnusrathfarooque@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  KHAN SAIMA PARVEEN 
Designation  MD Scholar Unani 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi, India-110005.

Central
DELHI
110005
India 
Phone  7977816298  
Fax    
Email  ksaimap05@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh,New Delhi.110005,India.  
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College and Hospital  
Address  Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi, India-110005 
Type of Sponsor  Government medical college 
 
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 Khan Saima Parveen  Ayurvedic and Unani Tibbia college and Hospital  Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh,New Delhi, India-110005.
Central
DELHI 
07977816298

ksaimap05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurvedic and Unani Tibbia College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Qurs kushta Faulad with Sharbat-e-Anar shirin  1 tablet of Qurs kushta Faulad (130mg) with 25ml of sharbat-e-Anar shirin twice a day for 2 months. 
Intervention  Qurs Kushta Khabsul Hadeed(tablet) with Sharbat-e-Anar shirin(syrup)   1 tablet of Qurs Kushta Khabsul Hadeed(130mg) twice a day with 25ml of sharbat--e-Anar shirin twice a day for 2 months 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Clinically diagnosed patients with iron deficiency anaemia.

2.Patients between the age of 18 and 60 years of either sex.

3.Hemoglobin Level more than 7gm/dl and less than 12 gm/dl for females or 13gm/dl for males.

4.Patients suffering from microcytic hypochromic anaemia on peripheral smear.

5.Serum ferritin level less than 30ng/ml.

6.Patients able to understand and follow the protocol for the duration of the study.

7.Patients having blood urea, serum creatinine, SGOT, SGPT, within normal limit.

8.Patients willing to participate in the study and sign the informed consent form.
1.Clinically diagnosed patients with iron deficiency anaemia.

2.Patients between the age of 18 and 60 years of either sex.

3.Hemoglobin Level more than 7gm/dl and less than 12 gm/dl for females or 13gm/dl for males.

4.Patients suffering from microcytic hypochromic anaemia on peripheral smear.

5.Serum ferritin level less than 30ng/ml.

6.Patients able to understand and follow the protocol for the duration of the study.

7.Patients having blood urea, serum creatinine, SGOT, SGPT, within normal limit.

8.Patients willing to participate in the study and sign the informed consent form.
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women.

2.Patients suffering from diabetes mellitus/tuberculosis/cardiovascular diseases/liver diseases/kidney diseases or any other co-morbidities.

3.Patient already taking treatment for anaemia.

4.Patients suffering from other type of anemia like pernicious anemia,thallasemia or megaloblastic anemia.

5.Patients with bleeding history, e.g., Abnormal uterine bleeding, piles/rectal bleeding,haemoptysis and hematemesis etc.

6.Patients taking blood thinners or any other drug which causes haemolysis.

7.Patients not willing to sign the consent form. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess the Safety and Efficacy of proposed compound unani formulation.

a.Improvement in Subjective parameters of IDA.

b.Improvement in objective parameters of IDA.

2.To compare the results of two Unani compound formulations in the management of Iron Deficiency Anemia in respect of safety and Efficacy.
 
1.To Evaluate efficacy.

a.Assesement of subjective parameters at baseline,15th,30th,45th and 60th day.

b.Assessment of objective parameters at baseline and after the 60th day.

2.To evaluate safety.

Haemogram, LFT, KFT at baseline and after 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in quality of life.  Assessment of QoL at baseline & after 60th day.  
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   25/10/2024 
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   This study is Randomized, parallel group, single blind, comparative clinical trial to evaluate the efficacy and safety of Qurs kushta khabsul hadeed and Sharbat-e-Anar Shirin in the management of iron deficiency anemia and to compare it’s efficacy with Qurs kushta faulad and Sharbat Anar Shirin.
According to the World Health Organization (WHO), anemia is defined as hemoglobin (Hb)  levels <12.0 g/dl in women and <13.0 g/dl in men . Anemia affects around 33% of the world’s population, and about half the cases are due to iron  deficiency. Preschool age children, women of child-bearing age, and pregnant women are  particularly at risk. Iron Deficiency anemia is the commonest cause of anemia in every  country of the world. Iron Deficiency Anemia (IDA) significantly impacts an individual’s  Quality of Life (QOL) concerning health, productivity, and socioeconomic well-being. Anemia results in a loss of up to 4.5% of GDP per annum in developing countries, equating  to 1.18% of India’s GDP.[38] Age-standardized Years Lived with Disability (YLDs) due to  anemia are higher in women than in men across socio-demographic indices. The management of this disorder involves dietary and drug supplementation with various  forms of iron. Despite the availability of iron supplements, anemia remains a global health  challenge. Also, there are many limitations of oral iron supplements, with the most common  being the frequency and severity of side effects. In contrast, Unani medicine, known for being safe, effective, readily accessible, cost-efficient, and with least adverse effects, can play a pivotal role in addressing this issue through research. The Unani system employs a holistic approach, with most anemia treatments combining iron  and hepatoprotective/hemopoietic agents. The purpose of this study is to evaluate the efficacy and safety of the combination therapy of  Qurs kushta e khabsul hadeed and sharbat-e-Anar Shirin in the treatment of IDA and to  compare the safety and efficacy data of the above-mentioned combined therapy in the  treatment of IDA on modern scientific parameters.
 
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