Effect of Uttar Basti and Pratimarsh Nasya with Shatpushpa Tail in the management of Stree Bandhyattava w.s.r. to Tubal Blockage and Anovulation.

Phase 2

Not yet recruiting

• Conditions: Female infertility of tubal origin. Ayurveda Condition: Stree Bandhyattava wsr Tubal Blockage and Anovulation, (2) ICD-10 Condition: N970||Female infertility associated withanovulation. Ayurveda Condition: Stree Bandhyattava wsr Tubal Blockage and Anovulation,

• Registration Number: CTRI/2022/09/045753
• Lead Sponsor: State Ayurvedic College and Hospital Lucknow

Brief Summary

**The study is entitled** “**A clinical study to evaluate the efficacy of ‘Uttar basti’ & ’ Pratimarsh nasya’ with ‘Shatpushpa tail’ in the management of ‘Stree bandhyattva’ w.s.r. Tubal blockage & Anovulationâ€.**

**Objective**- To evaluate the efficacy of ‘Uttar Basti’ and ‘Pratimarsh Nasya’ with ‘Shatpushpa tail’ in the management of ‘Stree Bandhyattava’ and gauging the improvement in causative factor (Tubal blockage & Anovulation) mainly responsible for female infertility.• To assess the conceiving rate during trial and follow up.

**Type of Study**:- **A Randomized open level parallel groups clinical trial**. **Period of Study:**- 6 Consecutive cycles ( 3 consecutive cycles with medication & 3 consecutive cycles with out medication). **Follow up period:**- During trial- 2 follow ups  After trial- 3 follow ups **Sample size:-** Minimum **30 patients** will be registered. **Grouping of Patients:- Group A**- Minimum **15 patients of Tubal blockage** . **Group B**- Minimum **15 patients of Anovulation** . Both group will be treated with same trial drug ‘Shatpushpa tail’ in the form of‘**Uttar basti’ & ‘Pratimarsh nasya**’.

**Inclusion criteria:-**

• Age between 20 to 42 years .• Patient coming with primary and secondary infertility • Patients coming with unilateral/ bilateral/ partial tubal blockage. • Patients coming with Complaints of Ovulatory Dysfunction (as per Follicular study).

**Exclusion criteria:-**• Age below 20 and above 42 years.• Patients coming with menstrual disorders like- Menorrhagia, Menometrorrhagia, Secondary Amenorrhea of more than three months.• Patient coming with acute inflammatory/ infectious state of Genital Organs like- PID, Endometriosis, Genital tuberculosis, Genital Prolapse, etc. • Patient coming with Complaints of infertility with Cervical / Vaginal /Unknown factor. • Any congenital anomalies of Genital Organ.• Patient suffering with any Systemic/ Acute illness   â€¢ Any significant abnormality found in Husband’s Seminogram.

**Diagnostic criteria:-** **HSG** (for Tubal blockage) **TVS** (for Follicular Study)

**Clinical Procedure**:- It will be executed in minor OT of Prasuti Tantra and Stri Roga Department of State Ayurvedic College, Lucknow.

**Drug, Dose and Duration ( In each cycle ):-**For adhonabhigat Snehana and swedana: ‘Shatpushpa tail’ / ‘Dashmool kwath’ (5 days) For ‘Anuvasana Basti’: ‘Shatpushpa tail’ -60 ml (two times) For ‘Asthapana Basti’: Madhu, Saindhava lavan, Shatpushpa tail, Shatpushpa kalka, Dashmool kwath - 700 ml (one times)  For ‘Uttar Basti’: ‘Shatpushpa tail’ 3- 5 ml (3 days) For ‘Pratimarsh Nasya’ : ‘Shatpushpa tail’ 2 drops in each nostril twice daily  for three consecutive cycle For Dhavan karma : Dashmool kwath

**Assessment criteria:-**Assessment will be done on the basis of changes seen in the Subjective and Objective criteria.

**Subjective criteria:-**• Abnormality in menstrual cycle like interval, duration, amount of bleeding, pain. • Other associated symptoms like stress, insomnia.

**Objective criteria:-**• Conception • Tubal Patency • Ovulation • Endometrial thickness

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-09-19
• Study Start: 2022-09-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Age between 20 to 40 years 2) Patient coming with primary and secondary infertility 3) Patient coming with unilateral/ bilateral/ partial tubal blockage 4) Patient coming with complaints of Ovulatory Dysfunction as per follicular study.

Exclusion Criteria

• 1. Age below 20 and above 42 years 2) Patient coming with menstrual disorders like- menorrhagia, menometrorrhagia, secondary amenorrhoea of more than three months 3) Patient coming with acute inflammatory/ infectious state of genital organs like- PID, Endometriosis, genital tuberculosis, genital prolapse etc.
• 4. Patient coming with complaints of infertility with cervical/ vaginal/ unknown factor 5) Any congenital anomalies of genital organ 6) Patient suffering with any Systemic/ Acute illness 7) Any significant abnormality found in Husbands seminogram.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of trial therapy on subjective criteria like abnormalities in menstrual cycle - duration, interval, amount of bleeding , pain, and other associated symptom like stress and insomnia.	Final assessment will be done after completion of trial of 6 Months.
And on Objective criteria-	Final assessment will be done after completion of trial of 6 Months.
Conception , Tubal patency, Ovulation, Endometrial thickness.	Final assessment will be done after completion of trial of 6 Months.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome will be done on the basis of changes seen in subjective and objective criteria	six months

Trial Locations

Locations (1)

State Ayurvedic College and Hospital Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic College and Hospital Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Piyusha pandey

Principal investigator

8874081065

piyushapandey26@gmail.com