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临床试验/CTRI/2025/01/079712
CTRI/2025/01/079712招募中2 期

Effect of Krishnadi churna and Madhutailik Basti in the management of Polycystic Ovarian Syndrome- Clinical Trial and In-silico study

Faculty of Ayurveda Institute of Medical Sciences BHU1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
B) Serum LH on day 2 or 3 of menses

研究概览

简要总结

Polycystic Ovarian syndrome is the most prevalent endocrinopathy affecting women in the reproductive age group which has a negative impact on several organ systems and can lead to abnormal uterine bleeding, anovulation, altered serum lipid levels, acne, acanthosis nigricans, polycystic ovaries and infertility etc According to Ayurvedic classics, the whole deranged metabolic processes distributed in PCOS is considered as Dhatwagni Vikar or Bahudoshavastha, hence Basti therapy is given which pacifies Vata Dosha which in turn causes normalization of other doshas. PCOS is often referred to as a state of chronic inflammation , henceforth Krishnadi churna described in Charak Samhita in Shavathu chikitsa is given as a  trial drug whose constituents posses potent anti inflammatory properties.

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

入选标准

  • Female patients of Age group
  • 40 years. 2)Patients diagnosed with PCOS as defined by Modified Rotterdam Criteria ie if any two of the following are present (i)Clinical(Acne, hirsutism, hairloss) or Biochemical(raised total or free Testosterone ) evidence of hyperandrogenism. (ii) Oligo-Anovulation (Oligo-amenorrhoea (cycles more than 35 days apart or less than 8 menses a year ) (iii)Polycystic Ovarian Morphology ( more than or equal to 20 follicles per ovary in either ovary, more than or equal to 10 cm ovarian volume) 3) Both married and unmarried patients.

排除标准

  • Patient of age less than 16 and above the age of 40 years.
  • Patients with diagnosed cases of congenital malformation of uterus, adnexa or reproductive organs.
  • Benign and Malignant lesion of reproductive organs.
  • Endocrinal dysfunction like Thyroid Dysfunction, Adrenal Hyperplasia.
  • Women with chronic ailments (systemic diseases like TB, DM, jaundice, bronchial asthma, cardiovascular diseases, Chronic liver Disease etc.).
  • Patients with Anorectal disease like Haemorrhoids, fistula, fissures or having any history of psychological disorder.
  • Patient having Acute pelvic inflammatory disease.
  • Patient taking any hormonal therapy and history of Hormonal Contraception within 3 months prior to study , patient taking lipid lowering drugs or other drugs affecting Insulin Senstivity or Serum Androgen.

结局指标

主要结局

B) Serum LH on day 2 or 3 of menses

时间窗: A total of 4 follow ups at an interval of one month

C) LH/FSH ratio

时间窗: A total of 4 follow ups at an interval of one month

D) Serum Prolactin

时间窗: A total of 4 follow ups at an interval of one month

E) Serum TSH

时间窗: A total of 4 follow ups at an interval of one month

F) Serum Testosterone

时间窗: A total of 4 follow ups at an interval of one month

G) Serum AMH

时间窗: A total of 4 follow ups at an interval of one month

3) HOMA-IR

时间窗: A total of 4 follow ups at an interval of one month

b)Waist Circumference

时间窗: A total of 4 follow ups at an interval of one month

c)Hip Circumference

时间窗: A total of 4 follow ups at an interval of one month

d)Waist Hip Ratio

时间窗: A total of 4 follow ups at an interval of one month

2) Hormonal levels:

时间窗: A total of 4 follow ups at an interval of one month

A) Serum FSH on day 2 or 3 of menses

时间窗: A total of 4 follow ups at an interval of one month

Normalization of certain parameters that include-

时间窗: A total of 4 follow ups at an interval of one month

1)General Body Parameters

时间窗: A total of 4 follow ups at an interval of one month

a)BMI

时间窗: A total of 4 follow ups at an interval of one month

4) USG (Pelvis) Colour Doppler : Ovarian Volume

时间窗: A total of 4 follow ups at an interval of one month

Number and size of Dominant follicle

时间窗: A total of 4 follow ups at an interval of one month

Uterine Artery Resistive index

时间窗: A total of 4 follow ups at an interval of one month

5) C-reactive protein

时间窗: A total of 4 follow ups at an interval of one month

6) Lipid Profile

时间窗: A total of 4 follow ups at an interval of one month

7) Clinical Hyperandrogenism ( modified Ferriman-Gallway score)

时间窗: A total of 4 follow ups at an interval of one month

8)LFT and RFT Values

时间窗: A total of 4 follow ups at an interval of one month

次要结局

  • Improvement in the quality of life of PCOS patients pertaining to their physical mental emotional social & behavioural well being(A standard PCOS Questionnaire will be attempted at baseline before the start of treatment & at the end of 3 months that is after the end of treatment)

研究者

发起方
Faculty of Ayurveda Institute of Medical Sciences BHU
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Dravya Pandey

Institue of Medical Sciences Faculty of Ayurveda Banaras Hindu University

研究点 (1)

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