跳至主要内容
临床试验/CTRI/2024/12/078810
CTRI/2024/12/078810尚未招募2/3 期

A clinical trial to evaluate the efficacy of Vamana karma along with Kuberaksha vati on PCOS profile in the patients of Polycystic ovarian syndrome

Ayurvedic And Unani Tibbia College And Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月1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
The proportion of patients showing effect on PCOS Profile.

研究概览

简要总结

Now a days PCOS is rapidly raising globally due to sedentary lifestyles, lack of exercise, more intake of junk food, stressful life etc. However, Infertility, Diabetes mellitus, Endometrial cancer, Metabolic Syndrome, Endometrial Hyperplasia, Hypertension and Cardiovascular disease are the most worrisome medical outcomes. Current modern medical and surgical treatments for PCOS have many limitations like use of metformin for insulin resistance, ovulation induction agents like clomiphene citrate, human menopausal gonadotropins (HMG), laparoscopic ovarian drilling for ovulation induction, OCP (Oral Contraceptive Pills) etc. No single definitive and successful modalities are known to the day. In order to overcome these limitations and invasive therapies with side effects an effective treatment empowered by the principles and practice of Ayurveda is essential.Due to the multifactorial etiology and involvement of Dosha Dushya Sammurchhana at the cellular level, Shodhana is essential part of Ayurvedic management of PCOS along with Shamana. Numerous databases were explored through, but effect of vamana karma along with kuberaksha vati on PCOS profile in patients of PCOS have not been well studied yet.  So, to establish a standard of care in PCOS, the current study  has been planned with all previous hypothesis in mind as well as the findings of previous research studies. By this, we will have a deeper understanding of the changes that ’vamana karma’ along with kuberaksha vati brings about on the various hormones in PCOS patients, we will eventually be able to collect evidence based data on how vamana along with kuberaksha vati is effective in the management of PCOS from the novel perspective of the PCOS profile.

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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patients with any 2 or more clinical features of PCOS like- Amenorrhea or Oligomenorrhoea Clinical hyperandrogenism (acne, hirsutism) Polycystic Ovaries on USG.
  • and Patients fit for Vamana Karma.

排除标准

  • Patients who are contraindicated for vamana karma such as kshatkshina, atishtula,atikrusha,bala,vriddha,durbala,shranta,pipasita .
  • Patients suffering from Pelvic diseases like Endometriosis, PID, Fibroid uterus.
  • Organic lesions of reproductive tract like tuberculosis, carcinoma and congenital deformities.
  • Patients with renal or hepatic impairment (Sr. creatinine more than 1.8mg/dl along with Sr. Urea more than 60 mg/dl, SGOT and SGPT more than Five times of upper limit .
  • Patients having LDL and Triglycerides more than two times of upper limit.
  • Patients with co-morbid conditions such as Hypertension grade 2 (more than equal to 160/100mm of Hg) or more, Diabetes Mellitus (having HbA1c more than 7.5% with or without hyperglycemic medications.

结局指标

主要结局

The proportion of patients showing effect on PCOS Profile.

时间窗: Baseline,after vamana including sansarjana krama,Day 120.

次要结局

  • 1) The proportion of patients showing effect on status of menstruation (duration, interval, pain associated with menses), hirsutism, acne.(2) The proportion of patients showing effect on weight, BMI (body mass index), waist-hip ratio, lipid profile.)

研究者

发起方
Ayurvedic And Unani Tibbia College And Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Anjali Pradip Karande

Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi

研究点 (1)

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