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临床试验/CTRI/2024/08/072218
CTRI/2024/08/072218尚未招募Phase 3 4

An Open Randomized Comparative Clinical Study Of Madhumehaher Yog And Chandraprabha Vati In The Management Of Madhumeha With Special Reference To Type 2 Diabetes Melitus

APMs Ayurved Mahavidyalaya1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月17日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Blood Sugar level (BSL)

研究概览

简要总结

Diabetes is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. Symptoms of marked hyperglycemia include polyuria, polydipsia, polyphagia, and weight loss or gain. Based on similarities in signs and symptoms type 2 diabetes mellitus can be compared to its Madhumeha in Ayurveda. All the types of Prameha if not treated in time develop in Madhumeha. Ayurveda also believes that Madhumeha is Medodhatu dushtijanya vyadhi, underlying its connection with obesity and a sedantary lifestyle.

The key causes of Madhumeha are lack of exercise, poor dietary practices, heavy consumption of food containing Snigdha (unctuousness) and Guru (heavy) Guna and food that causes Kapha dosha vitiation. Ayurveda elaborated about Madhumeha in detail classifying it into 2 types - Santarpanottha & Apatarpanottha. The treatment modalities in Ayurveda include - Apataran, Medoghna Chikitsa, Dhatavagnideepan, Prasadan, Shaman Aushadhi, and Shodhan chikitsa.The study involves an open randomized comparative clinical study of Madhumehaher yog and Chandraprabhavati in the management of Madhumeha with special reference to Type-2 Diabetes Mellitus. Madhumehaher yog includes each 1 part: Haritaki, Bibhitaki, Amalaki, Nagjivha, Jambu, Nimba, Madhunashini, Chiraita, Kutki, Methika, Tejpatra. Chandraprabhavati includes: Chandraprabha, Vacha, Musta, Chiraita, Devdaru, Harida, Daruharidra, Ativisha, Pimpalimule, Chitrak, Trivrut, Dantimool, Ela, Tamalpatra, Twak, Vanshalochan, Dhanyak, Haritaki, Bibhitaki, Amalaki, Chavya, Vidang, Gajapippali, Suvarna Makshik, Sunthi, Marich, Pimpli, Javakhar, Sajjkshar, Saindhav, Padalavan, Bidalavan, Lohabhasma, Khadisakhar, Shilajit, Guggul.The study is carried out on 60 patients for 30 days. To evaluate the efficacy of trial drug in numerical data, Paired T-test and ordinal data Mann Whitney test. After drug and disease review collection and preparation of drug will be done, followed by drug authentication and standardization. Clinical features are taken as parameters to study drug effects and collected data will be presented. Statistical analysis and interpretation will be done.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • BSL- fasting 110mg/dl to 150mg/dl and/or post prandial 140mg/dl to 180mg/dl, only type 2 diabetes people, blood sugar in the inclusion range even with oral hypoglycemic drugs, newly diagnosed patients with hyperglycemia, patients having symptoms of diabetes.
  • polyuria, polydipsia, polyphagia, extreme fatigue,blurred vision, numbness or tingling in hands or feet.

排除标准

  • Patients on insulin therapy Patients with nephropathy, retinopathy,H/O diabetes ketoacidosis Pregnant women and lactating mothers Patients with type 1 diabetes Patients on steroids Immunocompromised patients Patients with diabetic wounds and non-healing ulcers.

结局指标

主要结局

Blood Sugar level (BSL)

时间窗: Baseline, on 30th day and on 60th day

Fasting plasma glucose

时间窗: Baseline, on 30th day and on 60th day

Post-prandial plasma glucose

时间窗: Baseline, on 30th day and on 60th day

Urine glucose level (fasting and post prandial)

时间窗: Baseline, on 30th day and on 60th day

Weight

时间窗: Baseline, on 30th day and on 60th day

BMI

时间窗: Baseline, on 30th day and on 60th day

Abdominal Circumference

时间窗: Baseline, on 30th day and on 60th day

Mid-arm circumference

时间窗: Baseline, on 30th day and on 60th day

次要结局

  • Prabhut Mutrata(Avil Mutrata)

研究者

发起方
APMs Ayurved Mahavidyalaya
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Aishwarya Santosh Kamble

APMS ayurved mahavidyalaya, sion

研究点 (1)

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