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临床试验/CTRI/2025/04/083816
CTRI/2025/04/083816招募中2 期

Efficacy Of Krishnatiladi Kashyam Ghanvati As Artava Janan (Mensturation) In Patients Of Avrita Vata Artava Dushti WSR PCOS (Phenotype D)

The Central Council for Research in Ayurvedic Science1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月9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
30
试验地点
1
主要终点
Krishnatiladi kashayam ghanvati may act as emmenogogue

研究概览

简要总结

Polycystic Ovarian Syndrome is a most common metabolic and endocrine disorder in women of reproductive age It affects an estimated 5 to13 percent females and up to 70 percent of women with PCOS worldwide remains undiagnosed  Symptoms of PCOS include Amenorrhea or infrequent menstruation irregular bleeding and infrequent or no ovulation and multiple immature follicles. Later complication of PCOS is associated with type 2 diabetes  heart disease and ovarian cyst. According to the Rotterdam consensus  PCOS is determined by the presence of at least two out of three of the following features: evidence of oligomenorrhea (cycles  greater than 35 days apart or less than 8 cycles per year) or anovulation or biochemical or clinical hyperandrogenism and Polycystic ovarian morphology  greater than or equal to 12 follicles measuring  two to nine  mm in diameter and or an ovarian volume greater than10 mL in at least one ovary) . Phenotype D  oligomenorrhoea / anovulation and PCOS without Clinical or biochemical hyperandrogenism. In Ayurvedic literature details as per PCOS is not described.  It is a syndrome involving Pitta and  Kapha  and Rasa dhatu Dushti Dhatwagni mandya and Artava Dushti.    It has been mentioned  in   Yogaratnakar Yonivyapchikitsa Adhyaya that after the use of decoction prepared from Krishna Tila (Sesame indicum Linn) Shelu (Cordia dichotoma Forst) and Karvi (Nigella sativa Linn) mensuration will start in three days. Krishna tila and Karvi is having Ushna Veerya these drug may initiate mensuration. So this study may evaluate the efficacy of KrishnaTiladikashayam  in dosage form of ghanvati  as artavajanan (emmenagogue). It may be more feasible dosage form for artavajanan on the PCOS (Phenotype D ) patients.

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

入选标准

  • patients having symptoms of PCOS phenotype D (oligomenorrhoea or anovulation and PCOS without Clinical or biochemical hyperandrogenism) 2 Artava kshaya and Amenorrhea or oligomenorrhea (cycles greater than 35 days apart or less than 8 cycles per year).
  • 3 Endometrial thickness is greater than 5mm in ultrasonography.

排除标准

  • Female patients having any other disease causing oligomenorrhoea and anovulation excluding PCOD on the above criteria.
  • Known case of adrenal hyperplasia, severe insulin resistance, androgen secreting neoplasm, thyroid abnormalities, cushing’s syndrome will be excluded.

结局指标

主要结局

Krishnatiladi kashayam ghanvati may act as emmenogogue

时间窗: baseline 7th day and 15th day of both menstrual cycle

次要结局

  • Improvement In Symptoms Of PCOS(Amount Of Menstrual Flow Duration of Menstrual Bleeding)

研究者

发起方
The Central Council for Research in Ayurvedic Science
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr. Shalini Varshney

Ayurvedic And Unani Tibbia College And Hospital

研究点 (1)

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