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临床试验/CTRI/2024/04/066450
CTRI/2024/04/066450尚未招募2/3 期

A DOUBLE ARM CLINICAL STUDY ON OBESITY INDUCED FIBROID UTERUS THROUGH LEKHANA BASTI IN YOGA BASTI SCHEDULE FOLLOWED BY SHAMANOUSHADI

CCRAS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月9日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Weight of the patient will be reduced

研究概览

简要总结

In India, ‘The prevalence of Fibroids is reported to be 37.65 percent in Rural population and 24 percent in the Urban population’. The Fibroid Uterus has an estimated incidence of 20% - 40% in women during Reproductive years. According to the Global burden of disease study, 4.7 million people died prematurely in 2017 as a result of Obesity. The study conducted in 2005-2006 shows that prevalence of Obesity in Indian women has been elevated from 10.6% to 12.6%.

The modern life style such as lack of physical activity, Sedentary life style and influence of high calorie diet that leads to Obesity. Obesity is a medical condition in which excess body fat is accumulated to an extent that it may manifest Diabetes, thyroid disorders, Atherosclerosis, Dyslipidemia, Hypertension and unwanted growth like neoplasia, Benign and Malignant tumors. The higher levels of circulating estrogen in obese women may lead to Endometrial disorders i.e., endometriosis, Fibroid Uterus, endometrial infections. Uterine Fibroids are also thought to be influenced by high concentration of Estrogens.The above mentioned Metabolic disorders are enumerated by acharyas under the heading of Santharponttha vikaras in Ayurveda.

Abnormal and excessive accumulation of Kapha and medodhatu will results into manifestation of Sthoulya and other Santarpana vikaras like Prameha, Granthi, Apachi and Arbuda and Apatarpana chikitsa is the line of treatment for them.

Accumulation of Udarasthameda dhatu in Sthoulya and formation of garbhashayagata Granthi are having common dosha, dhatu and sthana. Vitiated Kapha and Medodhatu gets deposited in garbhashaya layers like sub mucosal, intramural, sub serosal. Hence Samprapti and chikitsa of both the diseases are interlinked with each other.

The involvement of Medoja Granthi, Dusta Kapha, Dusta Medas is due to the predominance of Pruthvi and Ap Mahabhutha at the site of Apana vayu and produces Sanghatmaka and granthi vikruti. The Treatment is aimed at administering Dipana, Pachana dravyas with the dominance of Vayu, Agni and Akasha mahabhutha. Therefore Karshana, Lekhana, Medohara chikitsa is to be implemented.

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
25.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Diagnosed cases of Fibroid Uterus on the basis of Ultrasonography of the Abdomen and Pelvis.
  • Subjects(participants) who are having the size of Fibroid up to 5 cm.
  • Patients having a B.M.I.
  • 30 (moderate obesity).
  • Female patient with age limitation of 25 to
  • Patients having clinical features of Fibroid Uterus.

排除标准

  • Subjects(participants) who do not fulfill the inclusion criteria will be excluded from the study.
  • Disorders of reproductive tract such as Congenital anomalies, Tuberculosis, Carcinoma.
  • Subjects(participants) suffering with any Chronic illness, Uncontrolled metabolic disorders and systemic diseases.
  • Subjects(participants) suffering with HIV/VDRL/HBsAg/STD’s will be excluded.
  • Subjects(participants) who are having the Fibroid Size more than 5 cm.
  • Patients who are unfit for Basti.

结局指标

主要结局

Weight of the patient will be reduced

时间窗: 60 days

次要结局

  • the size of the fibroid uterus will be reduced(60 days)

研究者

发起方
CCRAS
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Chaithra T M

Ayurveda mahavidyalaya college and hospital

研究点 (1)

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