| CTRI Number |
CTRI/2025/07/090017 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurveda treatment in low sperm count. |
|
Scientific Title of Study
|
An open label randomized controlled clinical study to evaluate the combined effect of Virechana and Shamananga Sneha with Amrithaprasha Ghrita in the management of Ksheena Shukra vis-a-vis 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 |
Dr Thejesh H B |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No. 1 41/E Lalithadripura Road Alanahalli Mysore Mysore KARNATAKA 570028 India
Mysore KARNATAKA 570028 India |
| Phone |
8951265075 |
| Fax |
|
| Email |
thejeshdevaru@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Beena M D |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No. 1 41/E Lalithadripura Road Alanahalli Mysore Mysore KARNATAKA 570028 India
Mysore KARNATAKA 570028 India |
| Phone |
9538367282 |
| Fax |
|
| Email |
drpbsreddy@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Thejesh H B |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No. 1 41/E Lalithadripura Road Alanahalli Mysore Mysore KARNATAKA 570028 India
Mysore KARNATAKA 570028 India |
| Phone |
8951265075 |
| Fax |
|
| Email |
thejeshdevaru@gmail.com |
|
|
Source of Monetary or Material Support
|
| #41/E, JSS Ayurveda Medical College and Hospital, Lalitadripura Road, Alanahalli, Mysore, Karnataka, India - 570028 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Room No. 01, Department of Kayachikitsa, JSS Ayurveda Medical College and Hospital, #41/E Lalithadripura, Mysore,570028, 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 Thejesh H B |
JSS Ayurveda Medical College and Hospital |
JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No. 1 41/E Lalithadripura Road Alanahalli Mysore Mysore KARNATAKA 570028 India
Mysore KARNATAKA |
8951265075
thejeshdevaru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: BIJOPAGHATAJAKLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Standard care for Oligozoospermia | Group B Subjects diagnosed as Oligozoospermia with Standard of care will be observed for 30 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amrithaprasha Grhita, Reference: API, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Subjects who are married between the age group of 21-50 years irrespective of socio-economic status.
Subjects who fulfill the diagnostic criteria.
Subjects who are willing to provide informed consent after explaining the ingredients of the Amrithaprasha Ghrita for the study.
Subjects fit for Virechana Karma.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Combined Effect of Virechana and Shamananga Sneha in the management of Ksheena shukra Vis-à-vis Oligozoospermia. |
before treatment - 0th day
after treatment - 43rd to 55th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of standard of care and ayurvedic management in Oligozoospermia. |
before treatment - 0th day
after treatment - 43rd to 55th day |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
15/07/2025 |
| 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 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
|
Male infertility can be defined as an inability to induce conception, due to defect in spermatozoic functions like low sperm count, unhealthy sperm production, low sperm motility and altered delivery of sperms due to altered physiology of male reproductive system. Infertility is one of the major issues of concern among couples worldwide. Approximately 40-50% male infertility cases are reported in India, out of which sperm parameters are the main reason for 2% of cases. Oligozoospermia refers specifically to a condition in which sperm concentration below the lower reference limit of 15 million sperm/mL of ejaculate. The standard of care is antioxidants, vitamin supplements, clomiphene citrate, which increases the production of FSH and LH hormones which increases the testosterone production leading to increase in the sperm count. In Ayurveda we have scattered references of ksheena shukra mentioned under asta shukra dusti. Ksheena shukra is vata and pitta dosha pradhana. It is characterized by both qualitative and quantitative reduction in shukra dhatu. Shukra is one of the sapta dhatus. Shukra is the final dhatu that is created from the prasada bhaga (essence) of the majja dhatu and is also thought to be the essence of all the dhatus. Virechana is Vata anulomaka and Pitta rechaka, hence indicated in ksheena shukra caused due to vitiation of vata and pitta dosha. As quoted in Ayurveda classics, Ghrita is having shukra vardhaka property, hence shamananga snehana with Amritaprasha ghrita is chosen. Amritaprasha Ghrita is indicated in nashtashukra, durbala and streeprasakta rogi and has brimhana effect. |