CTRI/2024/10/075207尚未招募3 期
A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF LAUHADI CHURNA AND KASISA BHASMA IN THE MANAGEMENT OF PANDU WITH SPECIAL REFERENCE TO IRON DEFICIENCY ANAEMIA
DrAnamika Yadav1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年10月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Reduction in Sign and Symptoms of Pandu with in 12 weeks
研究概览
简要总结
The volunteers will be informed about the study protocol.Willing participants will be randomly selected as per computer generated table.The clinical reserch format will be prepared and validated. Prior to the study, approval will be taken from IEC, KSVAMC & RC, SU GANGOH, SAHARANPUR and CTRI registration will be done after selection,each participant will be tested individually and selected criteria. They are divided into two groups is a single centre, open label, Randomised, Interventional,Comparative Clinical Study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 Patients of either sex with age above 18 years to 60 years 2 Patient present with classical sign and symptoms of Pandu 3 Patient present with sign and symptoms of iron deficiency anaemia 4 Patient having Hb in the range of 7-10 gm/dl 5 Serum iron content less then 50ug /L 6 TIBC in the range of more than 350ug/dl 7 Microcytic hypochromic anaemia i.e. MCHC less then 34 gm per dl and MCV less then 80 fL 8 Only those patients having Pandu as an independent disease & not as upadrava 9 Patient willing to give informed consent to participate in trial.
排除标准
- •Patient with severe Anaemia or congenital anaemia.
- •Patient present with co- morbid disorder (D.M, T.B, R.A etc.)
- •Patient with poorly controlled hypertension.
- •Patient with concurrent serious hepatic disorders or renal disorders or any other systemic / serious complication like cerebrovascular / cardiovascular disease that may jeopardize the study.
- •H/o Hypersensitivity to the trial drug or any of its ingredients.
- •Patient had completed participation in any other clinical trial in past 6 months.
- •Pregnant or lactating women.
- •Patients having Kamla, Rakta-Pradara, Rakta-Pitta, Raktarsha, Raktasrava
- •Age below 18 years
- •SGOT level more than 40 unit/lit.
- •SGPT level more than 6 unit/lit.
- •S.creatinine level more than 1.5 mg/dl .
- •S.Urea level more than 30 mg/dl.
结局指标
主要结局
Reduction in Sign and Symptoms of Pandu with in 12 weeks
时间窗: Reduction in Sign and Symptoms of Pandu with in 12 weeks
次要结局
- 1 To Observe adverse adverse effects if any(2 Cost effective treatment)
研究者
Anamika Yadav
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre
研究点 (1)
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