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Clinical Trials/CTRI/2021/07/034716
CTRI/2021/07/034716Not yet recruitingPhase 3 4

A COMPARATIVE CLINICAL STUDY OF CHATUHA PRASRATIKA BASTI AND SATAVARI KSIRA PAKA IN THE MANEGMENT OF KSHINA SHUKRA WSR TO OLIGOZOOSPERMIA

Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur1 site in 1 country50 target enrollmentStarted: July 28, 2021Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
THE SCORING SYSTEM DEVELOPED BY MEHRA AND SINGH(1995) WAS ADOPTED

Study Overview

Brief Summary

Kshina Shukra is one among the Astavidha Shukra dushti, in which qualitative as well quantitative vitiation of Shukra dhatu occur. While describing the dushti associted with Shukra and Artava, Vagbhatacharya explained Kshina Shukra as a pathological condition caused by vitiated Vata and Pitta. Khsina Shukra somewhat resembles Oligozoospermia. Oligozoospermia also a disease of male reproductive system, in which there is quantitative reduction of the count of spermatozoa (<20million / ml). Kshina Shukra and Oligozoospermia conditions are not exactly same, but Oligozoospermia indicates quantitative vitiation of Shukra Dhatu (Kshina Shukra). In Allopathy various drugs like Testosterone, Clomiphene Citrate 25 mg orally etc. are being used to increase sperm count, However these drugs are expensive and producing several Adverse Effects like head-ache, blurred vision, stroke, seizure, shortness of breath, decreased testicular size, so we looking to alternative system especially Ayurveda and find out solution to increase sperm count motility and volume simultaneously. The study is open labelled parallel group trial to prove the efficacy of Chatuha Prasratika Basti and Satavari Kshira Paka (internally) in the management of Kshina Shukra w.s.r to Oligospermia. In one group, 25 patients will be administered with Chatuha Prasratika Basti for 15 days, next 25 patients will be administered with satavari kshira paka for 30 days.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
25.00 Year(s) to 50.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • 1.Patient with classical symptoms of kshina shukra 2.Patient should not take any other medicine for kshina shukra 3.Patient who are basti yogya.

Exclusion Criteria

  • 1.Sperm count above 20 million 2.Patients of azoospermia and aspermia 3.All congenital case of impotency 4.Necrospermia 5.Patient who had undergone surgical procedure for hydrocele varicocele etc 6.Patients suffering with STD, DM, TB, Typhoid ,Mallignancy 7.Any other conditions in which basthi is contraindicated.

Outcomes

Primary Outcomes

THE SCORING SYSTEM DEVELOPED BY MEHRA AND SINGH(1995) WAS ADOPTED

Time Frame: 45 Days

SUBJECTIVE CRITERIA

Time Frame: 45 Days

OBJECTIVE CRITERIA

Time Frame: 45 Days

SIGNS OF SAMYAK BASTHI KARMA

Time Frame: 45 Days

SEMINAL ANALYSIS

Time Frame: 45 Days

Secondary Outcomes

  • To find out the comparative efficacy of the treatment in both groups WITH THE HELP OF SCORING SYSTEM DEVELOPED BY MEHRA AND SINGH (1995), SIGNS OF SAMYAK BASTHI KARMA AND SEMINAL ANALYSIS(45 days)

Investigators

Sponsor
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur
Sponsor Class
Government medical college

Study Sites (1)

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