A Clinical Study to Evaluate the Effect of Arohana Anuvasan Basti with Gokshuradi Taila in the Management of Anovulation
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
Garbhajananamâ€.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
DR SWATHI C
Sri Jayendra Saraswathi Ayurveda College and Hospital
