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临床试验/CTRI/2025/02/080421
CTRI/2025/02/080421尚未招募Phase 3 4

THE EFFECT OF SUSHRUTOKTA KUTAJADI KASHAYA IN MADHUMEHA WSR TO TYPE 2 DIABETES MELLITUS

Govt Ayurveda College and Hospital Nipaniya Rewa1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月25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
50
试验地点
1
主要终点
Improvement in subjective parameters like 1. Prabhuta mutrata,Avila mutrata,Kshuadhikya,Pipasa adhikya,Nidradhikya, Baddhata

研究概览

简要总结

TITLE :

EFFECT OF SUSHRUTOKTA KUTAJADI KASHAYA IN MADHUMEHA W.S.R. TO TYPE 2 DIABETES MELLITUS.

AIM :

To assess the effect of Sushrutokta Kutajadi Kashaya in Madhumeha w.s.r. to Type 2 Diabetes Mellitus.

OBJECTIVE :

To describe the probable mode of action of Kutajadi Kashaya in treatment of Madhumeha.

To assess the efficacy of Sushrutokta Kutajadi Kashaya in improvement of clinical manifestations of Madhumeha.

           INTRODUCTION:

Diabetes Mellitus type 2 in ayurveda correlate with madhumeha under the heading of prameha described in bruhatrayee and laghutrayee, mostly observed in age group 30 to 50 years of age . Amongst the many dreadful conditions arising because of modern,day living, Diabetes Mellitus  is a giant disease considered as one of the archenemies of the humankind caused by improper diet and lifestyle.

It is often referred to as a silent killer. Diabetes and its complications pose a major threat to public health resources throughout the world. Looking at its gravity, the World Health Organization WHO has taken up a close vigilance and survey about this problem the world over. The WHO  statement on primary health care program states that there is a collective failure to deliver in line with these values which is painful and deserves our greatest attention. Also there is an inability of health services to deliver the level of national coverage that meets the stated demand and changing needs.

This scientific holistic work inspired from Ayurveda with a special focus on diet and lifestyle can seriously contribute into the DM management and primary health care program. Taking these facts into consideration, the present study was  undertaken to evaluate the effect of Ayurvedic diet and lifestyle  with Kutajadi Kwatha in Madhumeha .

NEED OF RESEARCH:

The prevalence of diabetes in India has risen from 7.1% in 2009 to 8.9% in 2019, 25.2 million adults are estimated to have diabetes, which is estimated to increase to 35.7 million in the year 2045.

India ranks second after China in the global diabetes epidemic with 77 million people with diabetes. Of these, 12.1 million are aged >65 years, which is estimated to increase to 27.5 million in the year 2045. It is also estimated that nearly 57% of adults with diabetes are undiagnosed in India, which is approximately 43.9 million.

Thus, measures of controlling and prevention of diabetes need to be done so as to manage and prevent the disease accordingly.

STUDY DESIGN:

·       Study type : Interventional

·       Purpose : Treatment

·       Maskingn : Open labelled clinical trial

·       Direction : Prospective

·       End Point : Efficacy

·       No. of group : single group

  • Sample size  50 patients.

TREATMENT REGIMEN:

  • Drug  Kutajadi Kashaya
  • Form  Kashaya
  • Duration  30 days
  • Follow Up  06 months.
  • Dose 30 ml twice a day before meal.
  • Anupana  lukewarm water koshna jala
  • DRUG - Kutajadi Kashaya  Su.Chi.11/8

CONTENT:

1. Kutaja

2. Kapittha

3. Rohitaka

4. Bibhitaka

5. Saptaparna

  • PROBABLE MODE OF ACTION:

All pramehas are tridoshaja while kutajadi kashaya is tridosha shamaka. kutajadi

kashaya having tikta kashaya rasa, ushna virya anti hypoglycaemic property.

kutajadi kashaya is tikta kasaya rasa pradhana having katu vipaka and ushna virya

with laghu,ruksha guna predominance.

Practically most of patients.with madhumeha having history of consumption of

viruddha ahara and unhealthy life style as described in ayurveda leads to excessive

vitiation of kapha, pitta, meda, mamsa dhatu is responsible for madhumeha.

So considering the kapha,mamsa,meda predominance in madhumeha tikta kasaya

rasa and katu vipak,ushna virya of kutjadi kashaya will be best kapha,mamsa,meda

shamaka.

Laghu ruksha guna and tikta kashaya rasa of kutajadi Kashaya with its deepana

pachana karma helps improve metabolism by the properties of amapachana

Ushna virya of kutajadi kashaya acts as vata shamaka, stroto shodhaka and kledaka

shoshaka, eliminates morbid doshas accumulated in the body

RESEARCH QUESTION:

Is Kutajadi Kashaya effective in relieving the symptoms of Madhumeha when taken

for 30 days ?

HYPOTHESIS:

NULL HYPOTHESIS:

H0  Kutajadi Kashaya is not effective in relieving the symptoms of Madhumeha.

ALTERNATE HYPOTHESIS:

H1  Kutajadi Kashaya is effective in relieving the symptoms of Madhumeha

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients fulfilling the Diagnostic criteria with classical symptoms of Madhumeha Patients of both sexes in the age group of 30-65 years.
  • Patients who are willing to give written consent for participation in this study.

排除标准

  • Patients with juvenile diabetes.
  • Patients having IDDM and receiving insulin (type 1).
  • Excessive blood glucose (FBS) greater than 375 mg/dl and (PPBS) greater than 500 mg/dl.
  • HbA1c greater than 9.0 percent.

结局指标

主要结局

Improvement in subjective parameters like 1. Prabhuta mutrata,Avila mutrata,Kshuadhikya,Pipasa adhikya,Nidradhikya, Baddhata

时间窗: 0 to 21 days

次要结局

  • To assess the effect of trial drugs in improving(the signs, symptoms as per assessment criteria)

研究者

发起方
Govt Ayurveda College and Hospital Nipaniya Rewa
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Deepak Prajapati

Govt. Ayurveda College and Hospital, Nipaniya Rewa

研究点 (1)

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