CTRI

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CTRI Number

CTRI/2025/09/094944 [Registered on: 16/09/2025] Trial Registered Prospectively

Last Modified On:

16/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Effect of ayurvedic panchakarma (Trivrutta avaleha virechana) and Putranjivak seed powder on low sperm count (oligospermia): A clinical study

Scientific Title of Study

A Randomized Open Controlled Clinical trial to evaluate the efficacy of trivrutta avaleha virechana followed by Putranjivak beeja churna in ksheena shukra w.s.r. (oligozoospermia)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Bhushan Appasheb Kale
Designation	PhD Scholar
Affiliation	Department of PG studies in Prasuti tnatra and striroga, Yashwant Ayurvedic College A/p. Kodoli
Address	Department of PG studies in Prasuti tnatra and striroga,Room No. 3, Yashwant Ayurvedic College A/p. Kodoli,Tal-Panhala, Kolhapur Department of PG studies in Prasuti tnatra and striroga,Room No. 3, Yashwant Ayurvedic College A/p. Kodoli,Tal-Panhala, Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	9175113314
Fax
Email	vaidyabhushankale@gmail.com

Details of Contact Person
Scientific Query

Name	Vishal Turlapati
Designation	HOD
Affiliation	Department of PG studies in Prasuti tnatra and striroga, Yashwant Ayurvedic College A/p. Kodoli
Address	Department of PG studies in Prasuti tnatra and striroga,Room No. 3, Yashwant Ayurvedic College A/p. Kodoli,Tal-Panhala, Kolhapur Department of PG studies in Prasuti tnatra and striroga, Room No.3, Yashwant Ayurvedic College A/p. Kodoli,Tal-Panhala, Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	9960217429
Fax
Email	vishalaturlapati@gmail.com

Details of Contact Person
Public Query

Name	Bhushan Appasheb Kale
Designation	PhD Scholar
Affiliation	Department of PG studies in Prasuti tnatra and striroga, Yashwant Ayurvedic College A/p. Kodoli
Address	Department of PG studies in Prasuti tnatra and striroga, Room No.3, Yashwant Ayurvedic College A/p. Kodoli,Tal-Panhala, Kolhapur Department of PG studies in Prasuti tnatra and striroga, Room No. 3, Yashwant Ayurvedic College A/p. Kodoli,Tal-Panhala, Kolhapur Kolhapur MAHARASHTRA 416143 India
Phone	9175113314
Fax
Email	vaidyabhushankale@gmail.com

Source of Monetary or Material Support

Yashwant Ayurvedic College Kodoli, Kolhapur, Maharashtra, India.416114

Primary Sponsor

Name	Bhushan Appasaheb Kale
Address	Yashwant Ayurvedic College Kodoli, Kolhapur, Maharashtra, India.416114.
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Bhushan Kale	Yashwant Ayurvedic College Kodoli	Research advisory commttee Yashwant Ayurvedic College, post graduate training and research centre, Kodoli,Maharashtra, India. 416114 Kolhapur MAHARASHTRA	9113314175 vaidyabhushankale@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
YASHWANT AYURVEDIC COLLEGE POST GRADUATE TRAINING AND RESEARCH CENTRE KODOLI RESEARCH ADVISORY COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N461\|\|Oligospermia. Ayurveda Condition: VANDHYA,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Putranjivak beeja Churna, Reference: Bhavaprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -ushnajala), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Ashvatha Phala churna, Reference: Sushruta samhita chikitsa sthan, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -ushnajala), Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	50.00 Year(s)
Gender	Male
Details	Male patients aged between 20 and 50 years. Diagnosed case of Oligozoospermia Sperm count less than 15 million/ml Male patients who have signed for consent form Male patients fit for virechana karma.

ExclusionCriteria

Details

Azoospermia.
Congenital disorders related to reproductive system like bilateral absence of the vas deferens, cryptorchidism, marfans syndrome, Klinefelter’s syndrome.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To evaluate the efficacy of trivrutta avaleha virechana followed by putranjivak beeja churna in ksheena shukra w.s.r. (oligozoospermia)	90 days

Secondary Outcome

Outcome	TimePoints
To compare the effect of trivrutta leha virechana followed by Putranjivak beeja churna over ashwatha phala churna in ksheena shukra (oligozoospermia)	90 days
To observe the efficacy of trivrutta leha virechana followed by Putranjivak beeja churna in ksheena shukra w.s.r. (oligozoospermia)	90 days
To achieve improvement in sperm count when given for 90 days.	90 days

Target Sample Size

Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

11/10/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Oligozoospermia, or low sperm count, is a major contributing factor in male infertility and poses significant challenges to conception. Modern treatment options often involve costly, invasive, or temporary measures with limited holistic benefits. Ayurveda describes Ksheena Shukra as a condition comparable to oligozoospermia, caused by depletion or vitiation of Shukra Dhatu, and prescribes both Shodhana (purification) and Shamana (pacifying) therapies for its management.

This clinical trial is designed as a Randomized Open Controlled study to evaluate the efficacy of Trivrutta Avaleha Virechana (therapeutic purgation) followed by Putranjivak Beeja Churna (herbal seed powder) in patients with Ksheena Shukra (oligozoospermia). Virechana with Trivrutta Avaleha aims to eliminate accumulated doshas and enhance Agni and dhatu metabolism, thereby creating a favorable milieu for Shukra dhatu formation. Subsequent administration of Putranjivak Beeja Churna, known for its Vrushya (aphrodisiac), Balya (strength-promoting), and Garbhasthapaka (pro-natal) properties, is expected to nourish and restore Shukra Dhatu.

The study seeks to assess improvements in sperm count along with clinical outcomes. The results are anticipated to provide scientific validation for classical Ayurvedic therapies and establish an evidence-based, cost-effective, and non-invasive alternative for managing male infertility due to oligozoospermia.