| CTRI Number |
CTRI/2024/07/071548 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross-over observation based on negative control on milk intake. |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the impact of daily consumption of A2 Cow milk on gut health in healthy individuals. |
|
Scientific Title of Study
|
Cross-over study to assess the importance of Go-Ksheera as Nitya Sevaniya Dravya on Gut Health |
| 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 Tarini Venkatanarayan |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of Swasthavritta, room number 7, Sri Sri College of Ayurvedic Science and Research Hospital, 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
7675854377 |
| Fax |
|
| Email |
tarini.venkatanarayan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakshith K R |
| Designation |
Associate Professor, Department of PG Studies in Swasthavritta |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of Swasthavritta, room number 7, Sri Sri College of Ayurvedic Science and Research Hospital, 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9743903965 |
| Fax |
|
| Email |
ramrakshi31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tarini Venkatanarayan |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of Swasthavritta, room number 7, Sri Sri College of Ayurvedic Science and Research Hospital, 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
7675854377 |
| Fax |
|
| Email |
tarini.venkatanarayan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research, 21st Km. Knakpura road, Udayapura PO, 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Tarini Venkatanarayan |
| Address |
Sri Sri College of Ayurvedic Science and Research, 21st Km Kanakapura Road, 560082 |
| 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 Tarini Venkatanarayan |
Sri Sri College of Ayurvedic Science and Research Hospital |
Out patient department and In Patient Department of Sri Sri College of Ayurvedic Science and Research Hospital, 21st km Kanakapura Road ,Bengaluru, Near-by communities and housing societies. Udayapura, Bengaluru
Bangalore
KARNATAKA |
7675854377
tarini.venkatanarayan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy, Assessment on Gut Health
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject recruitment after assessing Arogya Linga
2. Subjects consuming A2 cow milk without additives that contain caffeine
3.Subjects with self reported milk intolerance will be considered.
4. Subjects willing to give written consent and willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from any systemic disease - cardiovascular or metabolic diseases and under medication for the same.
2.Pregnant and lactating women
3.Subjects with participation in similar interventions of dairy or probiotic-containing product within 3 months before screening.
4.Subjects diagnosed with any gastrointestinal disorders or gastrointestinal disease, such as irritable bowel syndrome, colitis, ulcerative colitis, and celiac disease.
5.Current habitual alcohol intake and/or smoking.
6.Subjects not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Appropriate assessment of the effect of regular consumption of go ksheera on gut health.
Creation and validation of a gut health questionnaire.
|
Pre-Study Assessment - 0th Day
(1st Assessment)
2nd Assessment - 7th Day (after 7 days wash off for regular milk consumers, for consumers who do not have milk regularly - after minimum 5 out of 7 days of milk consumption)
3rd Assessment - 14th Day (after 7 days of recommended milk consumption pattern based on previous assessment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observing and analysing the effects of abstinence of milk in healthy individuals. |
Pre-Study Assessment - 0th Day
(1st Assessment)
2nd Assessment - 7th Day (after 7 days wash off for regular milk consumers, for consumers who do not have milk regularly - after minimum 5 out of 7 days of milk consumption)
3rd Assessment - 14th Day (after 7 days of recommended milk consumption pattern based on previous assessment) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/08/2024 |
| 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
|
Gut health is a state of physical and mental well-being in the absence of - Gastrointestinal complaints that require the consultation of a doctor, indications or risks for bowel disease and absence of confirmed bowel disease. It is impacted by various factors, but mainly by food articles consumed on a regular basis. Dairy and its products in a normal Indian diet constitute around 15% and 19% in Rural and Urban population respectively. Making it a factor that could influence the gut health of an individual. Milk is often called nature’s complete food because of being an ideal source containing most nutrients essential to human growth, sustenance and development. The classics of Ayurveda have mentioned Ksheera as a part of the Nitya Sevaniya Dravyas and as an Ajasrika Rasyana. Consumption of milk has become a subject of debate due to the various symptoms that arise due to lack of proper digestion of milk and the impact of it on the gut or GI Tract. Thereby, depriving many from getting the potential benefits of regular milk intake. Any disturbance in gut health can create unpleasant sensations - a state that is subjective and interferes with daily activities of individuals. Good gut health is closely linked to overall well-being and better immunity. Hence, this study aims to understand the role of daily consumption of go-ksheera in healthy individuals, focusing on the effects it has on gut health. |