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临床试验/CTRI/2025/02/080392
CTRI/2025/02/080392尚未招募Phase 3 4

Efficacy of Devdaru Kwath in reducing Blood Sugar as a Upshaya in Madhumeha ( Diabetes Mellitus ) A Pragmatic Randomized Control Trial

Chaudhary Brahm Prakash Ayurved Charak Sansthan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月3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
Reduction in Blood Sugar levels

研究概览

简要总结

Madhumeha is the disease of metabolic derangement and genetic predisposition related with each individual body constitution and systemic consideration. In Ayurveda Madhumeha has been described as one among the 20 types of Prameha & is a sub-type of Vatika Prameha in which patient passes excessive amounts of urine that tastes & looks like honeyi.iiIn Madhumeha the properties of urine is similar with that of Madhu i.e. of Kashaya and Madhura rasa, rooksa (dry) guna and honey like colour. Madhumeha is well described in ayurvedic major and minor samhitas. Though it is a subtype of Vataja Prameha it has more prevalence in the society and may be compared to diabetes mellitus of the modern medical sciences .The main factors involved in the pathogenesis of Prameha are Vata, Pitta, Kapha, Meda and Oja. Therefore the treatment of this disease should be Tridosha shamaka chikitsa along with Brimhan-Karshana and Rasayana chikitsa. Acharya Sushurt has narrated that all the Pramehas finally convert into Madhumeha, if not treated at the primary stage.

Diabetes mellitus is a chronic, debilitating disease characterized by hyperglycemia, insulin resistance, and impaired insulin secretion. As per International Diabetes Federation’s (IDF) fifth diabetes atlas, India’s prevalence of diabetes among 20-79 year olds is 9.2%. India is just second to China. Due to increase in prevalance of Type-2 DM in society and day by day increasing incidence of primary and secondary drug failures, it would be effective to introduce a drug as Upshaya along with the standard prescription prescribed by the physician.According to Vachaspatyam Upshaya word is derived from Upa+Shi-Ach (Samipashayane). According to Vaidyaka sabdha sindhu Vyadhi jnana heto is Upshaya. Upshaya word involves the factors which bring about happiness (Sukhanubandha) either by acting directly against the cause of the disease or the disease itself. According to Amarakosha it indicates permanent relief but not temporary.

As Devdaru has properties opposite to that of Kapha and Vata dosha it would be effective in reducimg blood sugar as it is said to be Kaphavataghna , Bhavprakash Nighantu , Kaiyedev Nighantu, Dhanvantari Nighantu has mentioned Devdaru as Pramehaghna, So the study to evaluate the efficacy of Devdaru Kwath as a Upshaya without disturbing the standard treatment protocol would be very helpful to asses the hypoglycemic effect of Devdaru as an adjuncture therapy in the form of Upshaya.

There is no such study conducted which involves the assessment of Madhumehi patients on the basis of Upshaya. This study will help to analyze that whether Devdaru kwath as a Upshaya has hypoglycemic effect or not without disturbing the standard prescription prescribed by a physician.

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 65.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients of both the gender between age of 18 to 65 years 2 Patients with fasting blood sugar more than equal to 126 mg per dl 3 Patients with PPBS more than 200mg per dl 4 Patients with classical signs and symptoms of Type2 Diabetes Mellitus 5 Patients with HbA1c more than 6 point 5 percent and less than 10 percent 6 Patients willing to provide consent to participate in the study.

排除标准

  • 1 Pregnant women and lactating mothers 2 Patients with serious hepatic cardiac or renal disorders or any chronic illness 3 Patients diagnosed with Type-1 Diabetes Mellitus.

结局指标

主要结局

Reduction in Blood Sugar levels

时间窗: 90 DAYS

次要结局

  • Improvement in Clinical Features of Madhumeha Alongwith Lower levels of FBS , PPBS, HbA1c(90 DAYS)

研究者

发起方
Chaudhary Brahm Prakash Ayurved Charak Sansthan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ankit Jha

Chaudhary Brahm Prakash Ayurved Charak Sansthan

研究点 (1)

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