A single arm clinical study to evaluate the combined effect of Shatapushpa taila Nasya and Phala sarpi yoni pichu in improving the endometrial receptivity
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Applebaums USSR score
Study Overview
Brief Summary
PROPOSED TITLE :
“A SINGLE-ARM CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF SHATAPUSHPA TAILA NASYA AND PHALA SARPI YONI PICHU IN IMPROVING ENDOMETRIAL RECEPTIVITYâ€
INTRODUCTION :
The ability of the endometrium to allow implantation is known as receptivity. Optimal receptivity is essential for a healthy pregnancy. Females who have poor endometrial quality may face various menstrual and infertility problems, often resulting from a thin endometrium. The endometrium undergoes changes during the menstrual cycle, and estrogen plays a critical role in the endometrial sensitivity to ovarian hormones. Any disturbance in estrogen levels can result in a thin endometrium. Treatment for a thin endometrium involves synthetic estrogen administration, which can cause severe side effects. Thus, alternative methods are required to regulate estrogen synthesis and improve endometrial quality. According to Sushruta Samhita, four crucial factors are required for conception in which “ Kshetra†is Garbhashaya, which can be correlated to endometrium. Acharya Sushruta has mentioned pre-conceptional care, whereas Dalhanacharya focuses on Garbhasthapana and Garbhastitikarana. Acharya Vishwamitra’s commentary on Sushruta Samhita mentions presencesukshma kesha pratikasha beeja raktavaha sira in garbhashaya which can be correlated in the context of garbhashya tarpana. Phalasarpi has Garbha sthapaka , Yoni doshahara, Putrapada, Pumsavana properties. In Kashyapa Samhita, Shatapushpa-Shatavari kapla adhyaya, Shatapushpa is mentioned as having properties of rutupravartani, yonivishodhana, putraprada and veeryakari. Shatapushpa also known as Anethum sowa Roxb contains phytoestrogens that exhibit properties similar to endogenous estrogen. Nasal administration allows for a quick local effect and has a direct effect on the hypothalamo-pituitary axis, which leads to ovarian stimulation and ultimately impacts the endometrium. Drug administration through the vaginal route is effective due to better drug bioavailability to the uterus, hence can be given to improve endometrium receptivity.
METHODOLOGY : Minimum of 12 participants satisfying inclusion criteria will be selected from Sparsh women’s Hospital and IVF centre, after getting IEC clearance from SMBT Ayurveda College and CTRI registration.The baseline data will be assessed using Applebaum’s (USSR) score on the day of recruitment of the study, Day 15th of menstrual cycle (M1) after getting written informed consent. Treatment will be initiated with pratimarsha nasya using Shatapushpa taila from Day 6th – Day 13th of the immediate menstrual cycle (M2), Then from Day 15th-Day 21st of the same menstrual cycle (M2), yoni pichu with sterile Phalasarpi will be given. Post-assessment will be done on Day 15th of next menstrual cycle (M3) using Applebaum’s (USSR) score. This score will be compared with their initial score to determine the effectiveness of the treatment.
DURATION OF THE STUDY – 18 MONTHS
ESTIMATED COST – Approximately Rs. 67,000/-
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Females in age group 20-35yrs, Having an endometrial thickness of less tha or equal to 7mm or having an Applebaum’s (USSR) Score less than 16 out of 20 in the Pre-test, With a Menstrual cycle between 24-38 days, Who are eligible for TVS scan.
Exclusion Criteria
- •Subjects having compliance with the interventions Females who are already diagnosed with Carcinoma of the reproductive tract, Congenital anomalies of the reproductive tract, Active inflammatory disease, Sexually transmitted infections, and Uncontrolled systemic diseases such as diabetes and hypertension, Subjects who are on Oral-contraceptive from the last 3 menstrual cycles, Subjects unfit for nasya intervention.
Outcomes
Primary Outcomes
Change in Applebaums USSR score
Time Frame: 3 menstrual cycle of the patient
Secondary Outcomes
- Difference in menstrual cycle in terms of frequency, duration and flow volume(3 menstrual cycle of the patient)
Investigators
Dr Prashant Zinjad
Amrita School of Ayurveda