Efficacy of Aardra and Shushka Guduchi [Tinospora cordifolia (Willd) Miers] in the management of Madhumeha (Type-II DM): A Comparative open label Randomized controlled clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To access clinically the comparative anti-diabetic activity of Aardra (TCa) and Shushka (TCs) Guduchi by assessing the blood glucose level and HbA1c level
研究概览
简要总结
INTRODUCTION -
Diabetes mellitus is a sovereign disease considered as one of the arch-enemies of mankind, resulting due to faulty diet and lifestyle. It is a group of metabolic disorders characterized by hyperglycemia caused by an absolute or relative deficiency of Insulin There are 3 main types of Diabetes mellitus - 1) Type-1 DM 2) Type-2 DM 3) Gestational DM. In Ayurveda texts, the characteristic features of "Madhumeha" shows remarked resemblance with the syndrome of Diabetes Mellitus -2 (Type-2 DM). Madhumeha is a tridoshaja vyadhibut our ancient scholars mainly emphasized on vitiation of Kapha dosha, Medodusthiand Meda dhatwagni mandya. For disintegrating the pathogenesis, there must be a single drug or a formulation at the level of dhatwagniand counteracting Kapha dosha and Meda dhatu.
Guduchi (Tinospora cordifolia) is having Katu-Tikta-Kashaya Rasa, Laghu Guna, Ushna veerya and Tridoshaghnaactivity which may help in the disintegration of the pathogenesis of *Madhumeha.*Again in Madhumeha, there is Ojakshyaya (Oja is equivalent to Bala) and Guduchiis having the property of Balya and Rasayana. Regarding the form in which Guduchi is used, classics of Ayurveda have advised using it in "Ardra" (fresh) form but in day to day practice unfortunately it is used in the *"Shushka"*form. Further, a few works have been reported towards evaluating the efficacy of the classically mentioned use of "Ardra Guduchi". Therefore, a clinical study to compare the anti-diabetic effect of Tinospora cordifolia - ardra (TCa)andTinospora cordifolia - shushka (TCs)isplanned.
OBJECTIVES OF RESEARCH -
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Primary objective - To assess clinically the comparative anti-diabetic activity of Ardra(TCa) and Shushka (TCs) Guduchi.
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Secondary objectives - * Analytical study (HPLC, HPTLC) of TCa and TCs.
* Quality of Life (QOL) Assessment
METHODOLOGY -
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Drug Identification - Certification from taxonomist and Dravyaguna specialist will be taken and a voucher specimen will be preserved.
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Drug Analysis - Analysis of TCa and TCs in HPLC and HPTLC method.
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Drug Preparation - The drugs are prepared in the college pharmacy or procured from any reputed pharmacy as suitable.
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Study Design- Three Armed Randomised Standard Controlled Trial.
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Sample Size = Total 60 ( 20 in each group)
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Group - A (TCa + Lifestyle modification) - TCa Ghan (aqueous solid extract) tablets, at a dose of 500 mg twice a day orally after breakfast and supper with lukewarm water.
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Group - B (TCs + Lifestyle modification) - TCs Ghan tablets, at a dose of 500 mg twice a day orally after breakfast and supper with lukewarm water.
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Group - C (Standard control) (Glimepiride + Lifestyle modification + Placebo capsules of wheat powder) - Glimepiride (1mg) tablets and 1 placebo capsule once a day (or titrate as per blood glucose level) orally 15 minutes before breakfast with water.
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Duration - 3 months
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Purpose of the trial - The purpose of the trial is the same as the primary objective of the research i.e. to evaluate clinically the comparative antidiabetic activity of Ardra & Shushka Guduchi (TCa and TCs).
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Findings if any - As the patient recruitment is not started yet henceforth the findings are going to be evaluated after completion of the study.
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Publication details - After completion of the thesis work, the study will be published in peer-reviewed journals.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Recently diagnosed (less than 1 year of diabetic history) cases of Type-2 DM and not taking any antidiabetic drug/Insulin since 2 months
- •Including both Pre-diabetes and diabetes cases Fasting Blood Sugar (FBS) ranges between 100 to 125 mg/dl in pre-diabetes and greater than 126 mg/dl to less than equal to 200 mg/dl in diabetes cases.
- •Post Prandial Blood Sugar (PPBS) ranges between 140 to 199 mg/dl in Pre-diabetes and greater than 200 mg/dl to less than equal to 350 mg/dl in diabetes cases.
- •HbA1c ranges between 5.7 % to 6.4 % in Pre-diabetes and greater than equal to 6.5 % to less than equal to 8 % in diabetes cases.
- •Presence of urine sugar
- •Frequency of urination 7 to 10 times per 24 hours and quantity and quantity greater than equal to 2500 ml
- •Accidentally diagnosed cases of Type-2 DM who visit the hospital for other complaints.
排除标准
- •Cardiovascular disorder with Type-2 DM
- •Malignant and accelerated Hypertensive
- •Pregnant woman and planning to be pregnant within 6 months
- •Lactating mother
- •Secondary Diabetes Mellitus
- •Patients undergoing regular treatment for diabetes or any other severe illness
- •CNS Disorder e.g. Encephalopathy
- •Subjects already suffering from the complications of Diabetes (Diabetes Nephropathy, Diabetic retinopathy, Diabetic Neuropathy etc.)
- •Poorly controlled Glycemic status (HbA1c greater than 8%)
- •Concurrent serious hepatic dysfunction (AST or ALT greater than 3 times of upper normal limit)
- •Subjects on steroids, oral contraceptives or estrogen replacement therapy
- •Hypothyroidism or hyperthyroidism
- •Patients under other clinical trials for more than 12 weeks.
结局指标
主要结局
To access clinically the comparative anti-diabetic activity of Aardra (TCa) and Shushka (TCs) Guduchi by assessing the blood glucose level and HbA1c level
时间窗: 1. Blood Glucose level - 0th day, 15 th day, 30th day, 45 th day, 60 th day, 75 th day, 90th day | 2. HbA1c level - 0th day and 90th day
次要结局
- 1. Analytical study (HPLC, HPTLC) of TCa and TCs(2. Quality of Life assessment.)