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临床试验/CTRI/2024/10/075271
CTRI/2024/10/075271尚未招募2 期

Efficacy of Qurs kushta Khabsul Hadeed and Sharbat-e-Anar shirin in Iron Deficiency Anemia - A Randomized comparative single blind clinical trial.

Ayurvedic and Unani Tibbia College and Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年10月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
38
试验地点
1
主要终点
1.To assess the Safety and Efficacy of proposed compound unani formulation.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

1.To assess the Safety and Efficacy of proposed compound unani formulation.

时间窗: 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

a.Improvement in Subjective parameters of IDA.

时间窗: 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

b.Improvement in objective parameters of IDA.

时间窗: 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

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

时间窗: 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

次要结局

  • 1.Improvement in quality of life.(Assessment of QoL at baseline & after 60th day.)

研究者

发起方
Ayurvedic and Unani Tibbia College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

KHAN SAIMA PARVEEN

Ayurvedic and Unani Tibbia College and Hospital

研究点 (1)

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