| CTRI Number |
CTRI/2026/02/104246 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| 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
|
A clinical trial: comparing two herbal treatments for low sperm count |
|
Scientific Title of Study
|
Evaluating the efficacy of Shwadamstradi yoga over Ashwagandha churna in Ksheena shukra with special reference to Oligozoospermia – a randomised control clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit Bahubali Khane |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BM. Kankanawadi Ayurveda Mahavidyalaya Post Graduate studies and Research Centre |
| Address |
Department of Rasayana and Vajikarana, KAHERs Shri BM. Kankanawadi Ayurveda Mahavidyalaya
Post Graduate studies and Research Centre
Shahapur, Belagavi 590 003, Karnataka, India
Belgaum
KARNATAKA
590003
India |
| Phone |
9284931992 |
| Fax |
|
| Email |
khaneajit9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Bhagaje |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri BM. Kankanawadi Ayurveda Mahavidyalaya Post Graduate studies and Research Centre |
| Address |
Department of Rasayana and Vajikarana, KAHERs Shri BM. Kankanawadi Ayurveda Mahavidyalaya
Post Graduate studies and Research Centre
Shahapur, Belagavi 590 003, Karnataka, India
Belgaum
KARNATAKA
590003
India |
| Phone |
7204727997 |
| Fax |
|
| Email |
bnamratabhagaje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Bhagaje |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri BM. Kankanawadi Ayurveda Mahavidyalaya Post Graduate studies and Research Centre |
| Address |
Department of Rasayana and Vajikarana, KAHERs Shri BM. Kankanawadi Ayurveda Mahavidyalaya
Post Graduate studies and Research Centre
Shahapur, Belagavi 590 003, Karnataka, India
Belgaum
KARNATAKA
590003
India |
| Phone |
7204727997 |
| Fax |
|
| Email |
bnamratabhagaje@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BM. Kankanawadi Ayurveda Mahavidyalaya
Post Graduate studies and Research Centre Shahapur Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Ajit Bahubali Khane |
| Address |
Department of Rasayana and Vajikarana, KAHERs Shri BM. Kankanawadi Ayurveda Mahavidyalaya
Post Graduate studies and Research Centre
Shahapur, Belagavi 590 003, Karnataka, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajit Bahubali Khane |
KLE Ayurveda Hospital and Medical Research Centre |
Srishti Fertility OPD No. 21 Department of Rasayana and Vajikarana KLE Ayurveda Hospital and Medical Research Centre Shahapur, Belagavi Karnataka India 590003
Belgaum
KARNATAKA |
9284931992
khaneajit9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KAHERs Shri BM Kankanawadi Ayurveda Mahavidyalaya Shahapur Belgavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha, Reference: Nasimi Doost Azgomi R, Nazemiyeh H, Sadeghi Bazargani H, Fazljou SMB, Nejatbakhsh F, Moini Jazani A, Ahmadi AsrBadr Y, Zomorrodi A. Comparative evaluation of the effects of Withania somnifera with pentoxifylline on the sperm parameters in idiopathic male infertility: A triple-blind randomised clinical trial. Andrologia. 2018;50(7):e13041. doi:10.1111/and.13041, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Madhu and Ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Subject present with sperm count less than 15 million per mL in semen analysis
Subjects willing to participate |
|
| ExclusionCriteria |
| Details |
Subject with sperm concentration less than 0.01 million per mL
diagnosed cases of hypothyroidism or hyperthyroidism
with current or previous malignancies
Diagnosed cases of Varicocele
Subjects with history of sexually transmitted diseases
Congenital anomalies
Uncontrolled diabetes
Total or partly obstructive oligospermia
Subject who used PDE-V inhibitors (like sildenafil) and glucocorticosteroid within the four weeks prior to enrolment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sperm count through semen analysis |
0th day, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective parameter- symptoms of Ksheena shukra like dourbalya, mukhashosha etc |
0th, 30th, 90th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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 Applicable |
| 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
|
Currently, the treatment available for male infertility remains extremely limited. Only specific conditions—such as surgically repairable varicoceles or hormone-treatable Hypogonadotropic hypogonadism has established therapies. Consequently, around 90% of infertile men receive no direct treatment despite being the primary cause. Instead, clinical interventions typically target their female partners. This approach imposes substantial financial costs and subjects women to multiple procedural risks. In classics, there is reference for treatment of ksheena shukra with vajikarna dravyas. Various Vrushya, Shukrala formulations are available and clinically practised. So, this study aims at exploring the easily available unexplored Vajikarana formulation and evaluate its efficacy in ksheena shukra wsrt oligospermia. In RCT, Ashwagandha churna was found to be significant in increasing Sperm count. We are testing the efficacy of Shwadamstradi yoga over Ashwagandha chruna in increasing sperm count |