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临床试验/CTRI/2019/07/020363
CTRI/2019/07/020363尚未招募2 期

A conceptual and comparative clinical study of Madhumehari Churna and Madhumehari Ghrit in the Management of Madhumeha .

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月19日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
To evaluate the effect of Madhumehari Ghrit in the management of madhumeha

研究概览

简要总结

INTRODUCTION

Ayurveda is science of life as it explains (the conditions of) the life. The purpose of science of life is maintenance of the health and alleviation of disease, of one that is ailing. This science of treatment is taught for the benefit of life.

As life in the modern era has becomes more commercialized and mechanical. The tendencies of a person has been changed a lot with respect to himself that’s why the lifestyle disorders like heart disease, diabetes, cancer etc. are now mostly seen. Incurable and chronic diseases are increasing in the society because of irregular diet pattern and stress conditions; one of them is Madhumeha, Which is mentioned in classical Ayurvedic texts. It can be co-related with DM (diabetes mellitus), which is a growing health hazard in developing countries like India.

Madhumeha is a type of 20 type of  Premeha .Which come under type of Vataj Prameha . The Samprapti (pathogenesis) and Nidan  was described in Charaka Samhita Nidan 4 and the Chikitsa of madhumeha described in ch.chi.6. In ch.chi.6/34  “सिदà¥à¤§à¤¾à¤¨à¤¿ तैलानि ***घृतानि चैव देयानि मेहेषà¥à¤µà¤¨à¤¿à¤²à¤¾à¤¤à¥à¤®à¤•ेषà¥***…†Charaka described that due to the dominance of vata in madhumeha medicated sneha  should be use for getting better result because sneha is best remedy for vata .So i choose to internal use of  madhumehari ghrit  in the management of  madhumeha  .The ghrit will be prepaired with  madhumehari churna  which is attested and estabilished drug in madhumeha.

Madhumeha is a type of 20 type of  Premeha .Which come under type of Vataj Prameha . The Samprapti (pathogenesis) and Nidan  was described in Charaka Samhita Nidan 4 and the Chikitsa of madhumeha described in ch.chi.6. In ch.chi.6/34  “सिदà¥à¤§à¤¾à¤¨à¤¿ तैलानि ***घृतानि चैव देयानि मेहेषà¥à¤µà¤¨à¤¿à¤²à¤¾à¤¤à¥à¤®à¤•ेषà¥***…†Charaka described that due to the dominance of vata in madhumeha medicated sneha  should be use for getting better result because sneha is best remedy for vata .So i choose to internal use of  madhumehari ghrit  in the management of  madhumeha  .The ghrit will be prepaired with  madhumehari churna  which is attested and estabilished drug in madhumeha.

NEED OF STUDY

As the madhumeha is burning problem today there is need to study deeply and implement the  Ayurvedic  principles in treatment of madhumeha as there are no side effects.

Ayurvedic treatment is of less value, without knowing its exact cause, as Samprapti Vighatana can only be done when we know its cause and how the patho-physiology happens.

Hypothesis:-

Null hypothesis:- The effect of  Madhumehari  Churna  equal with Madumehari  Ghrit.

Alternetive hypothesis:- Either Madhumehari Ghrit effectiveness more or less than Madhumehari  Churna.

 AIMS & OBJECTIVES

To evaluate the effect of  Madhumehari  Ghrit  in the management of  madhumeha.

To compare the effect of Madhumehari  Ghrit  and  standard drug Madhumehari  churna .

MATERIALS AND METHODS

Materials:-

For present study two types of materials will be utilized as categorized below.

1.Literary material: - Reference will be collected from classical Ayurvedic texts as well from previous research works/thesis, research articles from internet and modern science texts to explain fundamental principles.

2.Clinical material: - clinical study will be done on the patients of  Madhumeha in two groups to fulfill the above said objectives.

A.    Patient:- Patient fulfilling all the selection criteria, visiting OPD, IPD of NIA and  Bombaywala hospital, Jaipur.

B.     Laboratory:- Assistance will be taken from central lab of NIA, Jaipur.

C.     Drug:- Drug will be purchased and prepared through pharmacy of NIA, Jaipur.

METHODS

The main criteria of diagnosis of the patient will be based on the cardinal and associated signs, symptoms and investigations of the disease based on the Ayurvedic and modern texts.

CLINICAL STUDY

A clinical study will be done as under -

Administration of Drug

40 clinically diagnosed patients will be randomly divided into 2 Groups of 20 each as below:-

In first group 20 patients will be administered   Madhumehari  churna   in the dose of 5 gms. before meal 2 times a day with water for 2 months.

In second group 20 patients will be administered Madhumehari  Ghrit   in the dose of

6 grams  before meal 2 times a day with lukewarm water for 2 months.

Criteria for the assessment:

The effect of trial drug will be assessed in terms of Subjective & Laboratory parameters

Subjective assessment-****

All the patients registered for clinical trial will be asked for any changes in their clinical manifestations.

Objective assessment-

1.Blood sugar level – Fasting and Post prandial.

2.Lab investigations- CBC, E.S.R.

3.Urine test for blood sugar in urine.

4.Lipid profile.

These investigations will be carried out for the diagnosis of  Madhumeha  and to exclude any other systemic complications.

DURATION-

For 2 months

DIRECTION AND DIET***-***

As mentioned in classical  Ayurvedic  text.

FOLLOW UP***-***

All the patients will be reviewed after each 15 days for a period of 2 months. During the trial and follow up study the patients will be assessed on the basis of following parameters-

  1. Subjective improvement
  2. Objective improvement

Subjective improvement

All the patients registered for the present trial will be looked for any improvement in the symptoms mentioned in  Ayurveda  and modern texts and changes in their health. if any, produced after the course of therapy.

  1. Objective improvement

Various signs mentioned in  Ayurveda  texts and modern sciences will be looked into for any imprvement after the course of therapy.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Presence of cardinal symptoms of Madhumeha described in Ayurveda texts.
  • 2.Confirmed cases of DM type II on the basis of laboratory investigations.
  • 3.Patients having F.B.S. level ranges between 110 – 150 mg/dl and P.P. B.S. between 141 – 200 mg/dl.

排除标准

  • 1.Patient having age below 20 and above 70 years.
  • 2.Patient suffering from complication of DM.
  • 3.Patient having Type-I DM (IDDM).
  • 4.Patient having Type-II DM with any other serious systemic disease.
  • 5.Patient having a FBS more than 150 mg/dl and PPBS more than 200 mg/dl.

结局指标

主要结局

To evaluate the effect of Madhumehari Ghrit in the management of madhumeha

时间窗: 2 MONTH

次要结局

  • 1.To compare the effect of Madhumehari Ghrit and standard drug Madhumehari churna .(2 MONTH)

研究者

申办方类型
Government medical college

研究点 (1)

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