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临床试验/CTRI/2024/11/076915
CTRI/2024/11/076915招募中2/3 期

To study the efficacy of Karavellaka Swarasa Bhavita Haritaki Churna as Nitya Virechana in Sthula Pramehi (Obese Type II Diabetics) - A single arm open labelled pilot study.

Sushrutha Ayurvedic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年1月15日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
To assess the efficacy of the formulation Karvellaka Swarasa Bhavita Haritaki Churna as Nitya Virechana in Sthula Pramehi (Obese Type II Diabetics) – A single arm open labelled pilot study

研究概览

简要总结

Ayurveda describes a set of complex clinical conditions with frequent, abnormal micturition, collectively called Prameha which has similar symptoms in Diabetes Mellitus1. For the persons who indulge constantly in Avyayama, Divaswapna, Kaphavardhaka Ahara Vihara etc2, the Tridosha get vitiated, mix with Medas, get localised in Vasti and manifests has Prameha which can be considered as Kapha Pradhana Tridosha Vyadhi.3

 Diabetes Mellitus is marked by hyperglycemia due to absolute insulin deficiency or diminished biological effectiveness. Epidemiological data from a 2019-2021 National Family Health Survey study reveals alarming prevalence rates: 8.65% for males and 7.39% for females, with abdominal obesity affecting 51.77% of males and 57.91% of females.4 Furthermore, the study indicates an 8.4% pre-diabetes prevalence and 6.8% diabetes prevalence, with obesity increasing diabetes risk by 8.3-fold compared to normal weight individuals.5

 The selected poly-drug combination aims to manage Sthaulya and Prameha Roga, which share common causes and complications. Both being Santarpanjanya Vyadhis,6 requiring similar treatment. For Sthoola Pramehi, Apatarpana Chikitsa i.e. Shodhana, Udvarthana7 is the treatment protocol mentioned in classics. However, time constraints may make Shodhana (Vamana, Virechana) challenging, in such cases Nitya Virechana offers an alternative.

Haritaki (Terminalia chebula Retz) Churna, a well-established Nitya Virechana drug, has demonstrated anti-hyperglycemic properties due to its rich content of tannins and flavonoids, which reduce glucose absorption.8,9,10 Similarly, Karavellaka (Momordica Charantia L.) contains Charantin, a cucurbitane-type triterpenoid with proven antidiabetic effects, particularly in protecting pancreatic beta cells from toxicity.11,12,13 Notably, both drugs possess Teekshna, Ushna, and Rooksha Guna, enabling them to target Medas and align with the principles of Apatarpana Chikitsa.

 According to Charaka Kalpa Sthana (12/47), Dravya Guna Vruddhi enhances drug efficacy by giving Bhavana with the Swarasa or Kashaya of same Dravya or the Dravya which has similar properties. This reduces the required dosage, shortens treatment duration, and minimizes complications.

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
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Clinical symptoms of Sthula Pramehi
  • BMI more than 25
  • Pre diabetics levels with increased lipid levels and BMI more than 25.

排除标准

  • • Volunteers suffering from major Systemic diseases • Chronic diseases with long run of medications • Insulin dependent DM-II, HbA1C above 9 • Hypertensive above 150/100 mmHg • Pregnant ladies & lactating women • Participants currently taking medications or supplements that may affect the present study • Participants currently enrolled in any other clinical trials or having participated in any other clinical trial in the past 30 days.
  • • Participants with history or currently under substance abuse.
  • • Any other conditions which investigator things may jeopardize the study.

结局指标

主要结局

To assess the efficacy of the formulation Karvellaka Swarasa Bhavita Haritaki Churna as Nitya Virechana in Sthula Pramehi (Obese Type II Diabetics) – A single arm open labelled pilot study

时间窗: on 0 day and on 16th day

次要结局

  • 1. To assess the role of Nitya Virechana in Sthula Pramehi (Obese Type II Diabetics).(2. To prove the efficacy of Karvellaka Swarasa Bhavita Haritaki Churna as Nitya Virechana drug in Pre Diabetics with raised lipids & BMI.)

研究者

发起方
Sushrutha Ayurvedic Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Chavhan Amruta Pandurang

Sushrutha Ayurvedic Medical College and Hospital

研究点 (1)

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