| CTRI Number |
CTRI/2026/01/100566 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Daily Black Sesame Seed Consumption On Serum Calcium Levels in Post Menopausal |
|
Scientific Title of Study
|
Evaluating the impact of daily sesame seed consumption on serum calcium levels in middle-aged women over a 45-days Period A Randomized Controlled Trials (RCT) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Astha Amrute |
| Designation |
MD Scholar |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Bhopal |
| Address |
Sant Hirdaram Medical College Of Naturopathy And Yogic Sciences for women Department of Naturopathy Flour 2 Room No2 Bairagarh Bhopal mp
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
6267002211 |
| Fax |
|
| Email |
amruteastha663@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saraswati Tewani |
| Designation |
HOD Naturopathy Department |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Bhopal |
| Address |
Sant Hirdaram Medical College Of Naturopathy And Yogic Sciences for women Department of Naturopathy Flour 2 Room No2 Bairagarh Bhopal mp
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
6267002211 |
| Fax |
|
| Email |
shmcnysbhopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Astha Amrute |
| Designation |
MD Scholar |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Bhopal |
| Address |
Sant Hirdaram Medical College Of Naturopathy And Yogic Sciences for women Department of Naturopathy Flour 2 Room No2 Bairagarh Bhopal mp
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
6267002211 |
| Fax |
|
| Email |
amruteastha663@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Astha Amrute |
| Address |
Sant Hirdaram Medical College Of Naturopathy And Yogic Sciences Bairagarh |
| Type of Sponsor |
Private 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 Astha Amrute |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Bhopal |
Department of Naturopathy Floor 2 Room no 2 Sant Hirdaram Medical College Of Naturopathy And Yogic Sciences for women Bairagarh Bhopal mp
Bhopal
MADHYA PRADESH |
6267002211
amruteastha663@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee sant hirdaram medical college of naturopathy and yogic sciences for women bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E58||Dietary calcium deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
As usual daily lifestyle and diet |
participants will follow as usual daily life routine |
| Intervention |
Black Sesame Seeds |
Participants will consume 30 g of roasted black sesame seeds once daily for 45 days The dose will be pre packed in single day sachets to ensure accuracy participants will take the seeds in the morning preferably on an empty stomach or with breakfast and will be advised to chew them thoroughly Adherence will be monitored through daily telephonic follow up and weekly in-person visits with empty sachets collected to assess compliance |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
postmenopausal women for at least 1 year
no history of calcium supplementation or osteoporosis treatment in the past six months
willingness to consume black sesame seeds |
|
| ExclusionCriteria |
| Details |
individual below 45 or 65 years of age are excluded from participants
history of severe gastrointestinal disorder kidney disease or any condition affecting mineral absorption
current use of medications affecting bone metabolism
allergies or intolerance
gout or wilson disease
people on medication such as blood thinners |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether the daily consumption of black sesame seeds for 45 days increase on serum calcium levels in middle-aged women compared with a control group. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
black sesame seed consumption to examine adherence tolerability and adverse events associated with daily black sesame seed consumption over 45 days
|
45 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/01/2026 |
| 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="2"
Months="0"
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
|
Each participant will receive 30g of roasted black sesame seeds daily over a period of 45 days The dose will be measured using a standardized weighing machine and provided in pre-packed single-day sachets to ensure dose accuracy and improve compliance participants will be instructed to consume the seeds once daily in the morning preferably on an empty stomach or with breakfast the seeds may be consumed with warm water and participants will be advised to chew the seeds thoroughly before swallowing to enhance mineral bioavailability dosage will remain uniform across all participants adherence monitoring will be carried out through daily telephonic follow up which will be recorded in a participant log book Additionally weekly in person follow-ups will be conducted during which empty sachets will be collected to objectively assess compliance |