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临床试验/CTRI/2024/10/074549
CTRI/2024/10/074549已完成2 期

A Clinical Study to Evaluate the Effect of Arohana Anuvasan Basti with Gokshuradi Taila in the Management of Anovulation

DrGondhane Mayuri Ramkrushna1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月11日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
PRIMARY OBJECTIVE

研究概览

简要总结

The global incidence rate of infertility is 17.5%.1 In India, the prevalence rate of infertility ranges from

10-14%, according to the Indian Society of Assisted Reproduction (ISAR). The most common cause

of infertility is the anovulatory factor.2 Globally, 30-40%3of infertility cases are due to anovulation,

while in India, it is around 30%.4 Ovarian factors that contribute to infertility include anovulation or

oligo-ovulation and luteinized unruptured follicle.5 LH and FSH play a very important role in the

process of ovulation. So, if there are any variations in them then it leads to anovulation. In Ayurveda,

this condition can be compared to Abeejotsarga or Artavayukta Beejadushti, which is mainly caused

by a disturbance in the Vyana Vayu and Apana Vayu. The function of Vyana Vayu is Gati, which may

regulate the activity of FSH and LH.6 Similarly, Shukra Artava Utpatti and all reproductive activities

of the body are governed by Apana Vayu.7 Any disturbances in Vata may lead to conditions like

Alpapushpa, Nashtapushpa, and Nashtabeeja,8 wherein Rutu, Kshetra, Ambu, and Beeja9 are the most

important factors. Therefore, Anuvasana Basti is mentioned as the main line of treatment for conditions

like these.10 Basti administered in increasing doses is expected to promote folliculogenesis through

Bruhana Karma. Gokshuradi Taila, if administered in the form of Basti, acts as a “Vandhyanam

Garbhajananam”.11 It contains Gokshura, Adraka, Gudam, Tila Taila, Godugdha.12 These drugs mainly

possess the properties like Madhura Rasa, Guru-Snigdha-Tikshna Guna, and Vata-Kaphahara, which

lead to an impact over folliculogenesis. Considering all the above factors, it may help the ovulation

process by virtue of controlling the vitiated Vata Dosha, therefore, it is hypothesized that Gokshuradi

Taila administered in Arohana Krama of Anuvasana Basti may be beneficial in correcting the ovulation

process. Therefore, a current study entitled “A clinical study to evaluate the effect of Arohana Anuvasan

Basti with Gokshuradi Taila in the management of anovulation” is planned.

This was a single-arm, open-label clinical study conducted on 40 female patients aged 20-35 years diagnosed with anovulatory infertility. Recruitment began on 11 October 2024 and was completed on 09 April 2025. Each participant received Arohana Anuvasana Basti with Gokshuradi Taila for 9 consecutive days, with the final procedure completed on 18 April 2025. Based on final data analysis, 35 patients (87.5%) showed complete remission (confirmed ovulation with favorable endometrial features), 4 patients (10%) showed clinical improvement, and 1 patient (2.5%) showed no change. Notably, one patient achieved confirmed conception, supported by positive urinary pregnancy test and serum beta-hCG report. No adverse events were reported.

The results are incorporated into the thesis and are under consideration for publication

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
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Primary and Secondary both types of infertile patients having anovulation.
  • Patient eligible for Anuvasan Basti.

排除标准

  • Female patients having age less than 20 years and more than 45 years 2)Congenital deformities of reproductive tract 3)Sexually transmitted diseases (HIV, HBsAg, VDRL) 4)Patient with vaginal and cervical infection.
  • Hyperprolactinemia / Hypothyroidism.

结局指标

主要结局

PRIMARY OBJECTIVE

时间窗: 9 DAYS

To evaluate the therapeutic efficacy of Gokshuradi Taila Anuvasana Basti in Arohana Matra in anovulation

时间窗: 9 DAYS

次要结局

  • SECONDARY OBJECTIVE(1)To evaluate the therapeutic efficacy of Gokshuradi Taila Anuvasan Basti in Arohana Matra on endometrial thickness.)

研究者

发起方
DrGondhane Mayuri Ramkrushna
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR SWATHI C

Sri Jayendra Saraswathi Ayurveda College and Hospital

研究点 (1)

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