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临床试验/CTRI/2022/04/042107
CTRI/2022/04/042107尚未招募4 期

A comparative study to evaluate the effectiveness of “Darvyadi Kwathaand Nishamalaki Churna†in management of Madhumeha (Type-2 Diabetes)

Chaudhary Brahm Prakash Ayurved Charak Sansthan1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年3月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
82
试验地点
1
主要终点
Reduction in the value of FBS, Glucose in urine and HBA1C

研究概览

简要总结

Madhumeha is a clinical entity described in ayurveda as one of the types of VatajaPrameha. It is also mentioned that Madhumeha urine is sweet, slightly turbid and pale in color just like honey1 and each and every part of the body is sweetened in this disease. Madhumeha is Santarpan ahara viharjanya vyadhi in which Kapha Dosha and Meda Dhatu Dushya is dominant. The cardinal feature of prameha has been mention “avila prabhuta mutraâ€. Main causes of the disease mainly excessive use of dairy products, sugar products, navdhanya, rice, sea food, excess sleep, lack of exercise. Tridosha responsible for disease as prameha which is characterized by dhushyas such as Med, rakta, vasa, lasika, mansa, rasa, oja, kleda, majja, shukra . Symptoms of prameha includes, excessive thirst, prabhutavilmutra, hast pad taldaha, gurugatrata, swedadhikya, atinidra, kshudhadhikya, daurbalya. In Margavaranjanya Madhumeha the vitiated Kapha and Meda obstructthe passage of Vata. The obstructed Vata is vitiated again and carries Ojas to Basti thus manifests Madhumeha7. In Madhumeha kapha is increase and mix with kleda. Kleda and meda is similer in nature. Excessive kleda mix with kapha goes to vasti and due to gurutva guna do srotoavrodh and manifest disease.

These clinical manifestations are similar to manifestations of a clinical entity named as Diabetes mellitus. Diabetes Mellitus is a group of common metabolic disorders that share the phenotype of hyperglycemia. Depending on the etiology of the Diabetes Mellitus, factors contributing to hyperglycemia include reduced insulin secretion, increased insulin resistance leading to decreased glucose utilization.

For treatment of Madhumeha, it is said that physician should decide upon the therapeutic measures based on disease and strength of dosha.

 Darvyadi kwath**:** is herbal formulation for treatment of Madhumeha as mentioned in several proportion.

Daruharidra is tikta (~bitter) and kashaya (~astringnt) in rasha and virya is ushna (~hot potency) and Prabhava is Kaphaghna**Devdaru is tikta (~Bitter) rasha and virya is ushna (~hot potency) and Prabhava is Vatakaphaghna. Nagarmotha tikta (~bitter), katu (~pungent) and kashaya (~astringnt) in rasha and Prabhava is Kaphapittaghna.Amalaki is panch rasha without lavna rasha and virya is ushna (~hot potency) and Rasayana Haritki is panch rasha without lavna rasha and virya is ushna (~hot potency) and Rasayana Vibhitki is Kashaya (~astringnt) rasha and virya is ushna (~hot potency) and Vipaka is Madhura and Prabhava is Tridoshar and *Pitta Shamak.*Ayurveda has two ways of treatment viz. sodhan (purification) and shamana Chikitsa (pacificatory management). The etio-pathogenesis of Madhumeha, Shamana Chikitsa must be done with such drugs that possess Agni Deepana (digestion and metabolism enhancing) and Kleda nasaka (moistness removing) the aggravated Dosha. Drugs having Tikta (bitter), Kashaya (astringent) and Rooksha (dry) properties are mostly used in the management of Madhumeha. Darvyadi Kwatha possess above mentioned properties required for the management of Madhumeha (Diabetes)1

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients fulfilling the diagnostic criteria for Diabetes Mellitus framed by the AMERICAN DIABETES ASSOCIATION.
  • FBS-126-250mg/dl
  • PPBS 180-400mg/dl
  • HbA1c 6.4 % and more.
  • 5.Patient is taking anti oral diabetic medicine sulphonylureas dosage (glipizide not more then 20mg, glimipride not more then 8mg, glidazidie not more than 180 mg, pioglitazoe not more than 20 mg ) and bigunoids (metformin not more than 1000 mg)
  • Diagnosed case of Diabetes mellitus at least 6 month back.

排除标准

  • Patients below the age of 21 years and more than the age of 60 years.
  • Fasting Blood Sugar Level >250 mg/dl •
  • Post Prandial Blood Sugar Level >400 mg/dl
  • Patients depending on the insulin for blood glucose control.
  • Patients with diabetic complications.
  • Gestational diabetes.
  • Pregnant ladies and lactating mothers.
  • Patient is taking any other oral anti diabetic medicine or combination of any oral anti diabetic medicine.

结局指标

主要结局

Reduction in the value of FBS, Glucose in urine and HBA1C

时间窗: Day1, Day28, Day56, Day84

次要结局

  • Improvement in graded symptom of Dhatusamyata andVikaropshama Madhumeha(Day1, Day28, Day56, Day84)

研究者

发起方
Chaudhary Brahm Prakash Ayurved Charak Sansthan
申办方类型
Government medical college

研究点 (1)

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