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临床试验/CTRI/2025/05/086642
CTRI/2025/05/086642尚未招募3 期

Effect of Shatapushpadi Taila and Phalaghrita Nasya in Anovulation-An open label comparative clinical study

Dr Suma Patil1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月19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
40
试验地点
1
主要终点
Anovulation

研究概览

简要总结

Anovulation condition is one among the ovulatory dysfunction  . Approximately 75% of anovulatoy women of any cause have polycystic ovaries and 20- 50% women with normal ovulation demonstrate ultrasound findings typical of polycystic ovaries.When compared with levels found in normal women, patients with persistent anovulation have higher mean concentration of LH but low or low normal levels of FSH.The characteristics feature of anovulation in PCOS is the arrest of growth of antral follicles after reaching a diameter between 5-8mm.

Because of low FSH follicular growth arrested at different phases of menstruation and because elevated level of LH there will be hypertrophy of theca cells and more production of androgens from theca or stroma cells, hence ovulation cannot occur  .

In Ayurveda classics there are no direct references available for this disease,but many scattered references are available in different samhita. Acharya Sushrutha quotes artavakshaya lakshanas in Doshadhatumalakshayavriddhi adhyaya ,they are Yathochitkala adarshana(irregular), alpadarshana (scanty flow) . Nastabeejartava is caused by vitiation of Vata and Kapha,which impairs the Uttarottaradhatu Vridhi resulting in Rasa Kshaya, this affects the Artava Utpatti which is an Upadhatu,due to impaired Kapha does Avarana which results in anovulation. Ovulation induction is the first line of treatment for the Anovulation.

There are number of drugs are used for ovulation induction but they are reported to have various adverse effects,such as Ovarian hyper stimulation syndrome,Ovarian enlargement,Ovarian cancer,Ectopic pregnancy,Premature delivery,nausea, vomiting,breast tenderness,headache etc.

Hence there is a need to find some safe and effective drug for ovulation. So as for Shatapushpadi taila many studies are conducted in the form of Basti,Pana,Nasya in vandhyatwa,PCOS,Artavakshaya and Anartava,because Shatapushpadi taila has qualities like Rutupravartaka, Yonishukravishodha, Putraprada and Deepana, Pachana.  And for Phala ghrita the research studies were conduted in the form of Snehapana, Uttarabasti Vandyatwa / female infertility ,development of ovarian follicle . Phala ghrita possess the properties like Yonishukradoshahara,Ayushya,Medhya,Pushti.Therefore the drugs selected for this study are Shatapushpadi taila and Phala ghrita for Nasya.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • 1.Complain of irregular cycles. 2.K/C/O PCOS. 3.Subjects fulfilling the diagnostic criteria. 4.Age group.
  • from 18 to 35 years.Subjects who are fit for Nasya karma.

排除标准

  • Known case of chronic illness like cardiac diseases, thyroid dysfunction and diabetes mellitus, chronic rhinitis and sinusitis.
  • Known case of Pelvic inflammatory disease, benign and malignant lesions of reproductive organs, tuberculosis of reproductive organs.
  • Congenital deformities of female reproductive system.
  • Patients who are under treatment like oral contraceptives/steroids, emergency pills or any reproductive hormones.

结局指标

主要结局

Anovulation

时间窗: 3 months

To compare the efficacy of Shatapushpadi Taila and Phala Ghrita Nasya in

时间窗: 3 months

次要结局

  • To evaluate the effect of Shatapushpadi Taila Nasya in Anovulation.(To evaluate the effect of Phala Ghrita Nasya in Anovulation.)

研究者

发起方
Dr Suma Patil
申办方类型
Other [self]

研究点 (1)

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