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临床试验/CTRI/2024/12/078417
CTRI/2024/12/078417尚未招募2/3 期

A clinical trial to evaluate the effect of Sakanjik Japakusum and Jyotismati Patra on Nastartava (Secondary Amenorrhea)

Dr. Samruddhi Heramb Narawade1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1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
Regularization and reappearance of menses within 90 days of treatment period

研究概览

简要总结

Menarche is a precious milestone of puberty. Hypothalamo pituitary gonadal axis (HPO Axis) plays a main role in the regulation of the cyclical changes that happens in the female reproductive structures like uterus, ovaries, vagina etc. If the basic health of women governed by rasa dhatu is deteriorated then the upadhatu artava would also be influenced. There is mainly derangement of vata. Apana Vata is said to be the governing force of menstrual flow and vyana vayu is responsible for rasarakta chankramana. Vitiated Apana vayu and vyana vayu leads to hampering of their normal function.The Principle treatment of Nastartava - Samshodhana, Shaman in the form of Agneya Dravyas, use of Swayonivardhana Dravyas and Nidana Parivarjana".

The selected drug for the study contains japakusum, jyotismati, and kanjika.

Japakusum has kasaya, tikta rasa, katu vipak, sita virya & kaphapittasamak properties. jyotismati is tikshna gunatmak katu, tikta rasatmak, katu vipaki, ushna viryatmak, Medhya, & vatakaphasamak as well as artavajanaka . kanjika is amla rasatmak, ushna viryatmak, amla vipaki, laghu, tikshna gunatmak, vatakaphanasak and dahasamak.

Nastartava is considered as amenorrhoea in modern science. In Nastartava there is obstruction of passage by doshas because of that obstruction women’s menstruation stops. The meaning of nasyati means artava does not end at all, it just doesn’t seem to be coming out. In Nastartava Artavavaha Strotas and artavavahidhamanis gets blocked by vitiated Vata and  Kapha dosha which leads to artava adarshanam (Nastartava).  Nastartava is also seen as one of the manifestation of yonivyapads like vandhya yonivyapad ,shandhi,arajaska and shushka yonivyapad. Sakanjik Japakusum along with Jyotishmati patra administered orally in form of vati which works on vitiated Dosha, Dhatu & established pathophysiology because of having Vata Kapha Shaman & Artava Janana properties which leads to Samrapti Vighatan and formation of Artava in the end.

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

入选标准

  • Patients of age group 15-40years.
  • Diagnosed cases of PCOS with chronic anovulation.
  • Hypothyroidism, Increased prolactin levels.
  • Low, high or normal FSH level & LH level.
  • Eating disorders, Stress.

排除标准

  • Cushing syndrome.
  • Empty Sella.
  • Sheehan syndrome.
  • Abnormal karyotype.
  • Asherman syndrome.
  • Anatomical abnormalities.

结局指标

主要结局

Regularization and reappearance of menses within 90 days of treatment period

时间窗: 90days ( Three consecutive menstrual cycles)

次要结局

  • appearance of regular , cyclic menses with normal growth and secondary sexual characteristics.relieves the symptoms of PCOS,regularies(the hormones,)

研究者

发起方
Dr. Samruddhi Heramb Narawade
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Samruddhi Heramb Narawade

Sri Jayendra Saraswathi Ayurveda College and Hospital, Chennai

研究点 (1)

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