An open label double arm randomized clinical study to compare the efficacy of ashwagandha arka orally with phalaghrita matra basti and ashwagandha ksheerapaka orally with phalaghrita matra basti in vandhyatva w.s.r to anovulation in infertility
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
Study Overview
Brief Summary
Infertility is a significant global health concern, affecting nearly 17.5% of the adult population, with anovulation accounting for about 30% of female infertility cases. Anovulation occurs due to disturbance in the hypothalamic–pituitary–ovarian axis, often influenced by improper diet, lifestyle, and stress, leading to failure of ovum release. In Ayurveda, infertility is termed Vandhyatva, which includes both failure to conceive and inability to sustain pregnancy, and is mainly attributed to Apana Vata dushti and Artava kshaya. Successful conception depends on the proper functioning of Rutu, Kshetra, Ambu, and Beeja, and impairment of Beeja results in Nashtartava (anovulation).
Conventional ovulation-inducing drugs may cause adverse effects such as reduced ovarian reserve, whereas Ayurveda offers safer alternatives. Ashwagandha (Withania somnifera), a potent Rasayana and Balya drug, has shown beneficial effects on ovarian function, folliculogenesis, and hormonal balance. Ashwagandha Arka is considered more potent due to its method of preparation, while Ashwagandha Ksheerapaka is traditionally used in reproductive disorders. Phalaghrita Matra Basti acts on Apana Vata and supports uterine and ovarian functions. Hence, a comparative clinical study is proposed to evaluate the efficacy of Ashwagandha Arka and Ashwagandha Ksheerapaka along with Phalaghrita Matra Basti in anovulatory infertility.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Subjects between the age group 20–40 years Subjects with regular and irregular menstrual cycle Subjects diagnosed with Polycystic Ovarian Disorder Subjects diagnosed with primary and secondary infertility due to Anovulation.
Exclusion Criteria
- •Patients with any systemic disorders which interfere with the course of treatment.
- •Patients diagnosed with premature ovulation failure, resistant ovarian syndrome.
- •Anatomical and developmental defects of ovary.
Investigators
Dr Sneha S Shastry
Sri Kalbyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre
