A Clinical Trial of an Herbal Liquid Supplement - 'DBPS' for Managing Blood Pressure
2026년 6월 1일 업데이트: Eetho Brands, Inc
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of DOSE for Blood Pressure Shot (DBPS) in Prehypertensive Subjects.
Prehypertension is a clinical condition characterized by systolic blood pressure (SBP) readings between 120 and 139 mmHg and/or diastolic blood pressure (DBP) readings between 80 and 89 mmHg, as per the Joint National Committee (JNC 7) and World Health Organization (WHO) guidelines.
Individuals falling within this range do not yet meet the criteria for hypertension but are at a significantly elevated risk of progressing to full-blown hypertension and developing associated cardiovascular diseases such as heart attack and stroke.
This stage is considered as a critical window for intervention, as timely and appropriate measures can potentially halt or delay the progression to more severe health issues.
연구 개요
상세 설명
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of 4-week supplementation regimen of 'DOSE for Blood Pressure Shot (DBPS)' in reducing systolic and diastolic blood pressure among prehypertensive adults.
DBPS is formulated as a liquid oral supplement specifically designed to support cardiovascular wellbeing.
The product is rooted in both preliminary scientific evidence and traditional medicinal practices, which indicate that it may exert blood-pressure lowering effects by influencing vascular tone and modulating inflammatory pathways within the body.
The active ingredients in DBPS are believed to help relax blood vessels, improve endothelial function, and reduce systemic inflammation, all of which contribute to healthier blood pressure levels.
연구 유형
중재적
등록 (추정된)
198
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Dr Manoj Kumar Srivastava, MD
- 전화번호: +91-0542-2281750
- 이메일: manojsrivastava39@yahoo.in
연구 장소
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Uttar Pradesh
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Varanasi, Uttar Pradesh, 인도, 221002
- Trimurti Hospital
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연락하다:
- Dr. Ram Murti Singh, MD
- 전화번호: +91-9415221720
- 이메일: ram.trimurti@gmail.com
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수석 연구원:
- Dr Ram Murti Singh, MD
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Varanasi, Uttar Pradesh, 인도, 221003 ,
- Jain Clinic
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연락하다:
- Dr. Harshit Jain, MD
- 전화번호: +91-9793036567
- 이메일: harsh656@gmail.com
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수석 연구원:
- Dr Harshit Jain, MD
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Varanasi, Uttar Pradesh, 인도, 221007
- Kashi Medicare
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연락하다:
- Dr Manoj Kumar Srivastava Srivastava, MD
- 전화번호: +91-0542-2281750
- 이메일: manojsrivastava39@yahoo.in
-
수석 연구원:
- Dr Manoj Kumar Srivastava, MD
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Varanasi, Uttar Pradesh, 인도
- Octavia Hospital
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연락하다:
- Dr Raghvendra Kumar Singh, MD
- 전화번호: +91-8765548689
- 이메일: raghvendras069@gmail.com
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수석 연구원:
- Dr Raghvendra Kumar Singh, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Men and women between the ages 18 and 65 years, inclusive, at the time of signing the informed consent.
- Seated clinic systolic blood pressure (SBP) in the range of 120 to 139 mm Hg and diastolic blood pressure (DBP) in the range of 80 to 89 mmHg confirming a prehypertensive state as per JNC 7 and WHO guidelines.
- In good general health as determined by a medical history, physical examination, vital signs, electrocardiogram (ECG), and routine clinical laboratory tests (hematology, clinical chemistry, urinalysis).
- Body Mass Index less than 30 kg/m2.
- Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception (e.g., oral contraceptives, intrauterine device, barrier methods with spermicide, surgical sterilization) from screening until the end of the study. Women who are postmenopausal (defined as amenorrhea for at least 12 consecutive months) or surgically sterile are eligible.
- Provide written informed consent to participate in the study after all procedures have been fully explained and questions answered.
- Willing and able to comply with all study procedures, visit schedules, and restrictions.
Exclusion Criteria:
- Diagnosed with Stage 1 Hypertension (SBP more than 139 mmHg or DBP more than 89 mmHg or Stage 2 Hypertension as per JNC 7 and WHO guidelines
- Evidence of secondary hypertension (e.g., renal artery stenosis, primary hyperaldosteronism, sleep apnea).
History of significant cardiovascular disease, including but not limited to:
(i) Myocardial infarction, stroke, or transient ischemic attack within the past 6 months.
(ii) Symptomatic heart failure or left ventricular ejection fraction less than 40%.
(iii) Cases of class III and class IV congestive heart failure (CHF) as defined by the New York Heart Association.
(iv) Unstable angina pectoris or revascularization procedure within the past 3 months.
(v) Significant valvular heart disease or complex congenital heart disease by medical history.
- Use of any medications (prescription, over-the-counter, herbal supplements, certain vitamins/minerals) known to affect blood pressure or interfere with study product absorption/metabolism within 14 days prior to the dosing visit, or unwillingness to stop them for the study duration.
Organ Function Impairment:
(i)Impaired hepatic function (Alanine aminotransferase [ALT] or Aspartate aminotransferase more tan 2 times the upper limit of normal [ULN]).
(ii)Impaired renal function (serum creatinine level more than 132.6 μmol/L or estimated Glomerular Filtration Rate [eGFR] less than 60 mL/min/1.73m2).
(iii) Serum potassium outside the normal range (less than 3.5 mmol/L or more than 5.5 mmol/L).
- History of uncontrolled diabetes mellitus (e.g., HbA1C level more than 7.0% and/or FBS more than 125mg/dL or use of diabetes medications).
- Any chronic diseases that may interfere with study participation or pose additional risk to the subject.
- A tobacco smoker or user of nicotine products in the 6 months prior to screening.
- Excessive alcohol consumption (Men more than 14 drinks/week and women more than 7 drinks/week).
- History of substance abuse or dependency within the last 1 year.
- Women who are pregnant or lactating.
- History of hypersensitivity or contraindication to the test product (DBPS) or any of its components or placebo.
- Participation in another clinical research study involving an investigational product within 30 days prior to screening or during the current study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: DBPS- Double dose
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
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DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
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실험적: DBPS -Single dose
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
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DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
|
|
위약 비교기: Comparator
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
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An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Systolic Blood Pressure
기간: Week 0 & Week 4
|
Change from baseline to end of the study (4 weeks) in the readings of Systolic Blood Pressure.
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Week 0 & Week 4
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diastolic Blood Pressure (DBP)
기간: Week 0 & Week 4
|
Change from baseline to end of the study (4 weeks) in the readings of Diastolic Blood Pressure.
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Week 0 & Week 4
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Systolic and Diastolic Blood Pressure (SBP and DBP) as recorded by a twenty- four hour-ambulatory blood pressure monitor (24hr ABPM)
기간: Week 0 & Week 4
|
Change from baseline to end of the study (4 weeks) in the readings of Systolic and Diastolic Blood Pressure (SBP and DBP) as recorded by a twenty- four hour-ambulatory blood pressure monitor (24hr ABPM)
|
Week 0 & Week 4
|
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hsCRP level
기간: Week 0 & Week 4
|
Change from baseline to end of the study (4 weeks) in the level of hsCRP biomarker in serum.
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Week 0 & Week 4
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 15일
기본 완료 (추정된)
2026년 7월 30일
연구 완료 (추정된)
2026년 8월 30일
연구 등록 날짜
최초 제출
2026년 5월 8일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- DOSE/PHT/01/25; Ver2.0,22Apr26
- CTRI/2026/02/105085 (기타 식별자: Clinical Trial Registry, India)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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