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临床试验/CTRI/2024/07/069893
CTRI/2024/07/069893已完成3 期

Efficacy of Yavanyadi tablet as an add on medication in Type 2 Diabetes mellitus.

Dr Deepika GI1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年8月8日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Changes in blood parameters

研究概览

简要总结

Diabetes mellitus (DM) is a group of metabolic disorders characterized by a chronic hyperglycemic condition resulting from defects in insulin secretion, insulin action or both. Type 2 DM is marked by high blood sugar, insulin resistance and relative lack of insulin. The affected ones are managed with oral antihyperglycemic drugs, insulin & non-insulin injectable therapy. Diabetes mellitus can be correlated to Madhumeha (A type of Prameha) in Ayurveda. In the classical texts of Ayurveda, several formulations are mentioned in the context of Prameha chikitsa (treatment of Prameha) which are in practice. They are found to have hypoglycemic effects. In Kerala, Nishakathakadi yogam is the conventional Ayurvedic formulation used in T2DM.  Yavanyadi yogam is another polyherbal formulation mentioned in the classical textbook, Charaka Samhita in the treatment of Prameha. The constituents of the formulation are seeds of Yavani (Nigella sativa L), root of Usheera (Vetiveria zizanoides L. Nash), fruit rind of Abhaya (Terminalia chebula Retz.) & stem of Guduchi (Tinospora cordifolia (Willd.) Hook. f. and Thoms.). In the current scientific world, evidence-based approach is given much importance. The patient compliance to Ayurvedic medicines is a major problem in chronic disease management. People usually opt more easier form of drug administration. The medication in tablet form ensures a consistent dose, that is easy to consume. Yavanyadi yogam, is a less scientifically explored formulation in DM. Moreover, all the individual drugs have proven anti-diabetic action, pre-clinically. Hence, the present study is indented to determine the efficacy of Yavanyadi yogam which will be prepared as tablets thrice daily as an add-on medication in T2DM in comparison with Nishakathakadi yogam made into tablet,  in the management of Type 2 Diabetes mellitus.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.participants of age group 25-75 years 2.HbA1c greater than 6.5% 3.FBS level from 126mg/dl -250mg/dl or PPBS level from 200mg/dl-400mg/dl 4.Under stable dose of an anti-diabetic therapy.

排除标准

  • 1.HbA1c greater than 9.5% 2.Diagnosed cases of morbid cardiac & pulmonary HTN, metabolic complications like hyper-osmolar state
  • Pregnant or lactating women.

结局指标

主要结局

Changes in blood parameters

时间窗: Baseline,4weeks, 8weeks, 12weeks

1. FBS

时间窗: Baseline,4weeks, 8weeks, 12weeks

2. PPBS

时间窗: Baseline,4weeks, 8weeks, 12weeks

3. HbA1c

时间窗: Baseline,4weeks, 8weeks, 12weeks

次要结局

  • 1.For Standardization of the study drug physical parameters like Ash value, extractive value,TLC 2. Changes in Blood parameters of LFT, RFT 3.BMI

研究者

发起方
Dr Deepika GI
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Deepika G I

Govt. Ayurveda College Thiruvananthapuram

研究点 (1)

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