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临床试验/CTRI/2025/03/081654
CTRI/2025/03/081654尚未招募3 期

Efficacy of Ushahpana and Udvartana along with Tryushanadi Guggulu in the prevention of Sthaulya w.s.r to overweight-An Open Labelled Randomized Comparative Clinical Trial

Institute of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Relief in the symptoms of Sthaulya

研究概览

简要总结

It is an open labelled randomized comparative clinical trial to study the efficacy of Ushahpana and Udvartana along with Tryushanadi Guggulu in the prevention of Sthaulya w.s.r to overweight. Ayurveda is the science of healthy living, which believes in preventive and promotive health. Acharya Charaka describes the state of wellness which says that one endowed with practice of Hita Ahara and Vihara Sevana, conscious deeds, charity etc is healthy, which all lack in the condition of disease. Obesity as a disease, often lacks the characteristics of wellness, such as vitality and resilience, and is instead associated with negative impacts on physical and mental health. As per Acharya Charaka, scraggy is better in comparison of obese (Sthula), because in spite of both these possessing equal means/assets (for treatment),the obese person suffers more due to difficulty in treatment. Ushahpana as a procedure of Dinacharya is now out dated or vanished from our daily practice or if exists than followed wrongly, this is also one of the matters of interference, also drinking cold water has also shown REE (Resting Energy Expenditure) elevation in adults, suggesting an idea to explore the concept of Ushahpana with regard to weight loss or maintenance.  Acharya Sushruta while explaining Udvartana, says that it pacifies Vata and dissolves Kapha and Meda Dhatu all this three are contents of pathogenesis of Sthaulya (obesity), which indicates its beneficial use in prevention of obesity, being Sthula Vilekhanashcha, Yava is chosen for Udvartana. Tryushanadi Guggulu can quickly cure the diseases arising from Kapha, Vata and Medas, though severe hence, it’s used in overweight. Obesity is one of the most serious global public health challenges of the 21st century affecting every country therefore, World Health Organization has declared it as a global epidemic. According to National Family Health Survey, obesity prevalence rate in Gujarat state is 19.7% in males and 23.8% in females. The rate of obesity has increased to 3.9% in males and 3.1% in females respectively in 2022, the data is an alarming sign to find a remedy which is cost effective as well as feasible to prevent this life-threatening problem.

**Aim and Objectives:To assess the efficacy of Ushahpana and Udvartana along with Tryushanadi Guggulu, in the prevention of obesityw.s.r to overweight with regard to Leptin hormone levels.

**Materials and Methods:**45 patients with BMI ranging between 25-30 kg/m2, will be enrolled in three groups. Volunteers in Group Awill be given Tryushanadi Guggulu along with Ushahpana for 45 days, while volunteers in Group Bwill be given Tryushanadi Guggulu along with Udvaratana with Yava choorna for 45 days and volunteers in Group C will receive only Tryushanadi Guggulu for oral consumption.

**Results and Discussion:**Data generated during the above study will be present in a Systemic manner as shall be analyzed statistically. Where the important points of the review of literature, conceptual study, Analytical study will be discussed.

**Follow up:**After completion of procedure, follow up will be done for 1 month at the interval of 15 days.

ADR if any observed will be reported to the Pharmacovigilance cell of ITRA Jamnagar.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients who are willing to participate, presenting with at least 5 symptoms as per symptoms given in diagnostic criteria 1 viz.
  • Kshudrashwaas (Dyspnoea on Exersion), Atipipasa (excess thirst), Swedadhikya (Excess sweating at normal temperature/in normal condition), Daurgandhya (Body odour), Atikshudha (excess hunger), Nidradhikya (Excess sleep), Bharavriddhi (increase in weight), ChalaSphikaUdaraStana (Visible Movement in Hip-Abdomen-Breast), Angagaurava (heaviness in body), Ayathopachaya (Improper distribution of fat) 2)Body mass index (BMI) 25 to 29.99 Kg/m2 Over weight according to WHO Criteria 3)Waisthip ratio Men more than 0.95 and Women more than 0.85 4)Deranged values of lipid profile parameters.

排除标准

  • 1 Age less than 18 and more than 60 years and patients not willing to participate 2 Patients with Systemic Disorders like Diabetes mellitus both types, Hypertension, Liver cirrhosis, Fatty liver disease, Coronary heart disease, Renal diseases, Rheumatological disorders, Hypothyroidism, cancer, Bleeding disorders 3 Pregnant and lactating women 4 Patients suffering from infectious skin disorders and known c/o skin allergy 5 Patients on hormonal therapy and drugs.

结局指标

主要结局

Relief in the symptoms of Sthaulya

时间窗: 1 week,6 week

Reduction or maintenance in body weight, BMI, Waist-Hip ratio, Skin-fold thickness, Anthropometry.

时间窗: 1 week,6 week

Reduction in values of parameters in deranged lipid profile

时间窗: 1 week,6 week

Decrease or normalization in serum Leptin hormone level

时间窗: 1 week,6 week

次要结局

  • Improvement in LFT values(BT and AT within 6 weeks)

研究者

发起方
Institute of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Akshay Prajapat

Institute of Teaching and Research in Ayurveda Jamnagar

研究点 (1)

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