| CTRI Number |
CTRI/2025/04/084474 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational survey study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study of excessive consumption of Milk Tea on digestion and various systems of body. |
|
Scientific Title of Study
|
Observational study of effect of excessive consumption of Milk Tea on Agni, Annavaha Srotas and Rasavaha Srotas. |
| 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 Onkar Vaibhav Hendre |
| Designation |
PG SCHOLAR |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital |
| Address |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital, Dhanakawadi, Katraj, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7057208737 |
| Fax |
|
| Email |
onkar.hendre-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lata Dhananjay Patil |
| Designation |
MD (Associate Professor) |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital |
| Address |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital, Dhanakawadi, Katraj, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9403782466 |
| Fax |
|
| Email |
drpatillata1626@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lata Dhananjay Patil |
| Designation |
MD (Associate Professor) |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital |
| Address |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital, Dhanakawadi, Katraj, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9403782466 |
| Fax |
|
| Email |
drpatillata1626@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital, Dhankawadi, Katraj, Pune, Maharashtra, India 411043 |
|
|
Primary Sponsor
|
| Name |
Dr. Onkar Vaibhav Hendre |
| Address |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital, Department of Roga Nidan evam Vikriti Vigyan, Dhanakawadi, Katraj, Pune 411043 |
| 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 Onkar Vaibhav Hendre |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital, 1st floor Dept No. 1, Department of Roga Nidan evam Vikriti Vigyan, Pathology Laboratory Dhanakawadi, Katraj, Pune 411043
Pune
MAHARASHTRA |
7057208737
onkar.hendre-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Pune College of Ayurved Ethics Committee BV(DU)COA-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers who consume more than 3 cups of milk tea per day since more than 1 year
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers who consume more than 3 cups of milk tea per day since more than 1 year |
|
| ExclusionCriteria |
| Details |
Volunteers with terminal illness including cancer dementia including Alzheimer disease
advanced lung heart kidney and liver disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of excessive consumption of Milk Tea is seen on Agni, Annavaha & Rasavaha Srotas. |
36 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Formulation of questionnaire to assess effect of excessive consumption of milk tea on Agni, Annavaha & Rasavaha Srotas. |
36 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
14/04/2025 |
| 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="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
|
Tea
holds the title of being the most widely consumed beverage globally. India,
following China, stands as the second-largest producer of tea worldwide, while
also boasting the highest tea consumption rates globally. Approximately 80% of
the tea produced in India is consumed domestically, with around 64% of the
country’s population being regular tea drinkers.
According to historical
records, tea was first used as a medicinal beverage before the ancient Chinese
started drinking it. Today, someone may reject drinking coffee, Coca-Cola and
other modern beverages with various different reasons, including the reasons
for religious belief, but nobody can refuse to drink tea. In modern-day India, consuming tea has become an abundant part of daily
life, like to eating meals, across both rural and urban areas.
Even
though tea is traditionally consumed without any additives, in numerous Asian
cultures, the addition of milk is a widespread practice. Milk
addition to tea can decrease or completely inhibit tea antioxidant properties.
Based on the results of previously published
studies with consideration of the variations among individuals, tea type, milk
type, and methods of assessing antioxidant properties, the evidence appears to
point toward a negative (masking) effect for adding milk, especially skimmed
milk, to tea beverages because of the putative association between tea
polyphenols (such as catechins) and milk proteins (specifically caseins).
Furthermore, it appears that the role of milk fat has been neglected, despite
milk containing fat globules which may interact
with tea catechins as well. The negative effects of the addition of milk on the
activity of tea antioxidant have been broadly reported.
As per references, Chinese people started
drinking tea as medicinal beverage in the form of decoction which must be in
limited quantity. But if it is consumed in excessive quantity it can act as
causative factor in the body. Considering this
excessive quantity of Milk Tea as Aaharaj Hetu, it can first affect Agni and then pathogenesis proceeds
further. In the sequence of pathology Annavaha
and Rasavaha Srotas get affected
primarily. So the effect of excessive consumption of milk tea can be explored
primarily on these specific Srotas &
Agni. If we study excessive consumption of milk tea in
Ayurvedic perspective we can state its disadvantages accordingly and can advise
Nidan Parivarjan to patients which
will be half treatment for them.
Conduct of procedure: 1.
Enrollment of Volunteers:
Volunteers fulfilling inclusion criteria will be enrolled in the study. The
above topic and methodology will be explained to the volunteers. Then consent
form will be signed by volunteers.
2.
Frequency per day and the duration of tea consumption these
details will be noted.
3.
The effect on Agni,
Annavaha, Rasavaha Srotas will be noted.
4.
Statistical analysis of effect on Annavaha & Rasavaha Srotas
will be done on the basis of Annavaha
& Rasavaha Srotodushti Lakshanas mentioned in Charak Samhita Vimansthan 5th
Chapter and Charak Samhita Sutrasthan
28th Chapter respectively. Special questionnaire will be prepared for
the study and will be validated.
5.
Assessment of Agni will be done on the basis of its types.
The special questionnaire will be prepared and validated for the same.
6.
Discussion of effects of excessive consumption of Milk Tea
on Agni & Annavaha, Rasavaha Srotas
will be done.
7.
Conclusion will be drawn based on observations and
discussion.
|