| CTRI Number |
CTRI/2025/10/096682 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Can Sesame Seeds Help Improve Sperm Quality? A Study in Men with Infertility |
|
Scientific Title of Study
|
Impact of sesame seed powder consumption and sesame oil application on sperm quality in infertile males: A single group pre post study |
| 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 T Pradeep |
| Designation |
Post Graduate Scholar (Department of Narturopathy) |
| Affiliation |
Government yoga and naturopathy medical college and hospital,chennai-106 |
| Address |
Department of naturopathy,second floor,postgraduate block,Government yoga and naturopathy medical college and hospital,chennai-106
Chennai
TAMIL NADU
600106
India
Chennai
TAMIL NADU
600106
India |
| Phone |
9489446458 |
| Fax |
|
| Email |
pradeep.coolz.98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical officer cum Lecturer,Department of research |
| Affiliation |
Government yoga and naturopathy medical college and hospital,chennai-106 |
| Address |
Department of research,second floor,postgraduate block,Government yoga and naturopathy medical college and hospital,chennai-106
Chennai
TAMIL NADU
600106
India
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Pradeep |
| Designation |
Post Graduate Scholar (Department of Narturopathy) |
| Affiliation |
Government yoga and naturopathy medical college and hospital,chennai-106 |
| Address |
Department of naturopathy,second floor,postgraduate block,Government yoga and naturopathy medical college and hospital,chennai-106
Chennai
TAMIL NADU
600106
India
Chennai
TAMIL NADU
600106
India |
| Phone |
9489446458 |
| Fax |
|
| Email |
pradeep.coolz.98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital, Chennai
TAMIL NADU
600106
India |
|
|
Primary Sponsor
|
| Name |
Government yoga and naturopathy medical college and hospital |
| Address |
Government yoga and naturopathy medical college and hospital,
Chennai-600106 |
| Type of Sponsor |
Government medical college |
|
|
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 T Pradeep |
Government Yoga and Naturopathy Medical College and Hospital |
Department of Naturopathy, Second floor,Government Yoga and Naturopathy Medical College and Hospital, PG block,Arumbakkam,Chennai
106.TAMIL NADU
Chennai
TAMIL NADU |
9489446458
pradeep.coolz.98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital ,Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil for three months |
nil for three months |
| Intervention |
sesame seed powder consumption(5 grams)daily for three months and sesame oil application(1mL/kg)weekly for three months |
Participants will receive Sesamum indicum (black sesame) seed powder 5 g daily, taken orally after 15 min of breakfast, mixed in warm water. The powder will be pre-packed in weekly sachets for three months. Additionally, a weekly full-body application of sesame oil (1 mL/kg body weight) will be performed for 45 min with sunlight exposure, for a duration of three months. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Diagnosed with male infertility
2.Abnormal Semen parameters indicating one or more of the following: low volume, low sperm count, poor motility, abnormal morphology
3.Stable heterosexual relationship for at least one year.
4.Willingness to Participate
5.No fertility medication taken for the past two weeks
|
|
| ExclusionCriteria |
| Details |
1.Presence of genetic syndromes or congenital abnormalities affecting fertility.
2.Any surgical intervention that impairs natural fertility.
3.External morphological factors affecting fertility like varicocele, hydrocele, phimosis, erectile dysfunction and local cysts or lesions.
4.Aspermia which is complete absence of semen during ejaculation
5.Active Genital Infections or Sexually Transmitted Diseases(STDs)
6.Systemic Illnesses such as uncontrolled diabetes, cancer, or severe liver or kidney disease.
7.Substance abuse such as alcohol, tobacco.
8.Use of Fertility injections within one month
9.Major psychiatric Illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Semen Volume (ml)
2. Total Sperm Count (Million/ml)
3. Progressive Motility (%)
4. Normal Morphology Forms (%)
|
Semen analysis will be performed before the start of the intervention (baseline) and after completion of the 12-week intervention period to evaluate changes in semen parameters. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2025 |
| 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="5"
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
|
A single-arm pre and post study will be conducted involving 30 subjects. Participants will consume sesame seed powder daily at a dose of 5 grams, mixed with 150 ml of warm water between 92°F and 98°F, 15 minutes after breakfast. To ensure accuracy and compliance, the powder will be pre-measured and packed into seven single-dose sachets each week, with supplementation continuing for three months. In addition to oral intake, participants will receive a weekly full-body (from head to toe) external oil application using sesame oil under sunlight to aid absorption before being washed off with warm water between 92°F and 98°F. The duration of the oil application will be 45 minutes for three months at 1 mL per kg body weight. Pre and post assessments will be conducted using semen analysis. Subjects will be advised to maintain three days of abstinence from ejaculation prior to semen analysis. |