| 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
|
|
|
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
|
|
|
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. |