| CTRI Number |
CTRI/2025/11/097173 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| 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
|
A clinical trial to study the effect of panas beeja churna in patients with low sperm count |
|
Scientific Title of Study
|
Open Randomized control clinical trial of panas beeja churna in ksheenshukra with special reference to oligospermia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranjali Suresh Ashtikar |
| Designation |
Post Graduate Resident |
| Affiliation |
Hon. Shree Annasaheb Dange Ayurved Medical College,Ashta Tal-Walwa Dist-Sangli |
| Address |
Department of Strirog and Prasutitantra of Dhanwantari Hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8007797175 |
| Fax |
|
| Email |
pranjalisashtikar99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Katare |
| Designation |
HOD |
| Affiliation |
Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli |
| Address |
Department of Strirog and Prasutitantra of Dhanwantari Hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9881215521 |
| Fax |
|
| Email |
drdilipkatareashta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dilip Katare |
| Designation |
HOD |
| Affiliation |
Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli |
| Address |
Department of Strirog and Prasutitantra of Dhanwantari Hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9881215521 |
| Fax |
|
| Email |
drdilipkatareashta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Striroga and Prasutitantra of Dhanwantari Hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli, Maharashtra, Pin Code-416301, INDIA |
|
|
Primary Sponsor
|
| Name |
Pranjali Suresh Ashtikar |
| Address |
Department of Striroga and Prasutitantra of Dhanwantari Hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli, Maharashtra, Pin Code- 416301, 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 Pranjali Ashtikar |
Dhanwantari Hospital of ADAMC, Ashta Tal-Walwa Dist-Sangli, Maharashtra 416301, India |
OPD No 16, Department of Striroga and Prasutitantra, Dhanwantari Hospital of ADAMC, Ashta Tal-Walwa Dist-Sangli, Maharashtra 416301, India
Sangli
MAHARASHTRA |
8007797175
pranjalisashtikar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panas beeja churna, Reference: Bhavprakash Nighantu, Amradiphalvarga, 35-36, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | clomiphene citrate | Tab Clomiphene citrate 25 mg OD in evening after meals with water for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Married male patient.
Patient with clinical presentation of ksheenshukra.
Patient having sperm count less than 15 million per ml. |
|
| ExclusionCriteria |
| Details |
Patient having sexually transmitted diseases.
Patient with azoospermia, aspermia, teratozoospermia and asthenospermia.
Patient with varicocele or hydrocele.
Patient with systemic disorders like DM, HTN.
All congenital cases of impotency (mentioned as klaibya in Ayurvedic texts).
Surgical or traumatically injured condition of genital organs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of shukrakshaya and increase in sperm count |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing semen analysis report before and after giving panas beeja churna for 3 months |
3 months |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/12/2025 |
| 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
|
Infertility is a significant global health issue impacting millions of couples, affecting personal well being, family dynamics and societal structures. Oligospermia, a condition affecting male fertility, is a key focus in reproductive health reserach due to its prevalence among men worldwide. Researching ayurvedic treatments for oligospermia could enhance global health perspectives by integrating medicine and expanding treatment options. There is an essential need for efficient and safe ayurvedic formulations to address oligospermia. In Ayurveda, treatment for ksheenshukra is vrushya chikitsa. Panas beeja churna has properties like vrushya, tarpan, bruhan, balya and shukraprad, so it will be helpful in patients having sign and symptoms of ksheenshukra and low sperm concentration. Written informed consent will be taken to ensure compliance and transparency in research process. The sample size calculated is 68 by sample size formula. Simple random sampling technique will be used. All SOP of churna will be followed throughout the clinical trial. Observation will be done after semen analysis report. Result will be drawn on the basis of assessment criteria. Statistical discussion will be done on the basis of observation and result obtained during treatment. summary will be drawn and thesis will be summarized with the help of statistical analysis, conclusion will be drawn. |