| CTRI Number |
CTRI/2024/10/075500 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Lotus tea for hypertension |
|
Scientific Title of Study
|
Effect of Lotus tea on heart rate variability(HRV) and blood pressure(BP)
in patients with primary hypertension – A Randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pandiaraja |
| Designation |
Head of department Naturopathy |
| Affiliation |
International institute of yoga and naturopathy medical science |
| Address |
International institute of yoga and naturopathy medical science, Faculty Block, Department of Naturopathy, Room No: 1, kamarajar nagar chengalpattu
Chennai
TAMIL NADU
603001
India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohini |
| Designation |
Pg 2nd year |
| Affiliation |
International institute of yoga and naturopathy medical science |
| Address |
International institute of yoga and naturopathy medical science, Faculty Block, Department of Naturopathy, Room No: 1, kamarajar nagar chengalpattu
Chennai
TAMIL NADU
603001
India |
| Phone |
9597106500 |
| Fax |
|
| Email |
rohinibnys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohini |
| Designation |
Pg 2nd year |
| Affiliation |
International institute of yoga and naturopathy medical science |
| Address |
International institute of yoga and naturopathy medical science, Faculty Block, Department of Naturopathy, Room No: 1, kamarajar nagar chengalpattu
TAMIL NADU
603001
India |
| Phone |
9597106500 |
| Fax |
|
| Email |
rohinibnys@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Rohini |
| Address |
International institute of yoga and naturopathy medical sciences, Chengalpattu |
| 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 Rohini |
International Institute of Yoga and Naturopathy Medical Science |
International institute of yoga and naturopathy medical science, Faculty Block, Department of Naturopathy, Room No: 1, kamarajar nagar chengalpattu
Chennai
TAMIL NADU |
9597106500
rohinibnys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International institute of yoga and naturopathy medical science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D75||Other and unspecified diseases ofblood and blood-forming organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lotus petal tea |
The study group will receive 100 ml of lotus petal tea, prepared by boiling 20 grams of dried lotus petals in water, taken lukewarm on an empty stomach, twice daily (morning and evening) for 4 weeks. This results in a daily dose of 200 ml for 28 days. |
| Comparator Agent |
Naturopathy intervention |
the comparator group will undergo naturopathic intervention other than lotus petal tea for period of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants with primary hypertension and on oral hypotensive drugs with blood pressure above 140/90 mmHg, aged between 30 and 50 years no restrictions on gender or race and willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria included a history of surgery within the past year, women who are pregnant, menstruating, or lactating, patients over 50 years old, and those with hypertension associated with systemic complications such as diabetes or obesity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study will focus on heart rate variability (HRV) parameters, specifically assessing MeanRR (s), SDNN (ms), RMSSD (ms), pNN50%, LF (n.u), HF (n.u), and LF/HF Ratio. These metrics will be evaluated to determine any changes before and after the administration of Lotus tea in patients with primary hypertension. |
Baseline and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure |
Baseline: Before the intervention begins.
Week 1: Seven days after starting the intervention.
Week 2: Fourteen days after starting the intervention.
Week 3: Twenty-one days after starting the intervention.
Week 4: Twenty-eight days after starting the intervention.
Post-intervention: One week after completing the intervention. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/11/2024 |
| 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="0"
Months="1"
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
|
The study titled "Effect of Lotus tea on heart rate variability (HRV) and blood pressure (BP) in patients with primary hypertension – A Randomized controlled study" (abbreviated as L-HYVA) aimed to investigate the impact of Lotus tea on HRV and BP in individuals diagnosed with primary hypertension. This randomized controlled trial involved participants aged 30-50 years who were already receiving oral hypotensive medication.
Participants consumed 100 ml of Lotus petal tea daily for 4 weeks, prepared by boiling 20 grams of dried lotus petals in water and taken twice a day before meals. HRV and BP were assessed at multiple time points: baseline, weekly intervals during the intervention period, and one week post-intervention.
The primary outcomes included changes in HRV parameters such as Mean RR, SDNN, RMSSD, pNN50%, LF (n.u), HF (n.u), and LF/HF ratio. Secondary outcomes focused on alterations in systolic and diastolic BP levels.
The study design aimed to provide insights into whether Lotus tea could potentially modulate HRV and BP in hypertensive patients, contributing to the growing body of research on natural interventions for cardiovascular health management. |