Evaluation of the Effectiveness and Safety of Mool Healths customized Gut Health Regimen in participants with symptoms of Acidity-A Double-Blind Study
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To assess change in Acidity symptoms as measured by the PI adapted GSAS Score.
研究概览
简要总结
This is a prospective, double-blind, clinical study designed to evaluate the clinical effectiveness and safety of Mool Health’s customized Gut Health Regimen in participants experiencing symptoms of Acidity. The study will be conducted over a 28-day intervention period.
Eligible participants, aged 18 to 65 years, experiencing self-reported or PI diagnosed symptoms of Acidity, will be screened for inclusion and exclusion criteria. Following the signing of informed consent, participants will undergo a symptom evaluation conducted by the Principal Investigator (PI) using the PI Symptom Evaluation Form,the Online Symptom Evaluation Form and the PI adapted Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS). Participants meeting the eligibility criteria will be assigned Mool Health’s customized Gut Health Regimen based on the PI’s clinical evaluation, the participant’s online symptom profile, and an algorithm-based software designed by study sponsor to ensure consistent and accurate customization. The regimen will include one or more combination of ayurvedic and nutraceutical products aimed at alleviating Acidity symptoms.
Participants will follow the regimen for 28 days, with study assessments scheduled at five key time points. These include a screening visit, during which symptom evaluations and baseline assessments are performed; a kit dispensing visit for regimen assignment and participant education, which may occur on the same day or within 48 hours of screening; and weekly follow-up visits on Days 7, 14, and 21 to monitor symptom progression, compliance and adverse events. The final visit on Day 28 will serve as the end-of- study assessment to evaluate the overall effectiveness of the intervention and monitor adverse events. Throughout the study, a double-blind design ensures that neither the participants nor the Investigators are aware of the specific regimen composition, minimizing bias in outcome assessment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males/females of age of 18 years and 65 years
- •Patients with self-reported or physician-confirmed symptoms of Acidity for a minimum 2 weeks and currently experiencing at least 2 or more of the following symptoms: a) Heartburn b) Burning sensation c) Regurgitation d) Nausea/ vomiting e) Burping f) Bloating g) Sour / bitter taste h) Difficulty swallowing i) Chest pain j) Coughing k) Hoarseness l) Diarrhoea m) Headache
- •Participants who can and are willing to provide written Informed Consent.
- •Participants who are willing to follow dietary instructions
- •Female participant of child-bearing potential must agree to practice a medically acceptable method of birth control during the study period.
- •Participants must agree not to undergo any other type of treatment or procedure for his/her current condition during the study.
排除标准
- •Participant with a known history of allergy to any of the ingredients of the nutraceutical regimen or history or presence of multiple severe allergies.
- •Female participant who is pregnant or planning pregnancy during the study period or breastfeeding.
- •3.Participant with history of significant surgeries affecting esophageal or gastric function within the past 6 months.
- •Participant with active gastrointestinal ulcers or a recent history of peptic or duodenal ulcers.
- •5.Participant with hepatic disorders or fatty liver disease.
- •6.Participant with skin disorders related to immune function, such as seborrheic dermatitis 7.Participant with history of previous treatment with test product within the past 4 months.
- •8.Participant having a mental or physical condition that would, in the opinion of the Investigator, place the participant at an unacceptable risk or render the participant unable to meet the requirements of the protocol or interfere with the ability to provide consent or complete study requirements.
结局指标
主要结局
To assess change in Acidity symptoms as measured by the PI adapted GSAS Score.
时间窗: From baseline to Week 4.
次要结局
- 1. To evaluate change in Acidity symptoms as measured by the PI adapted GSAS Score.(2. To assess changes in quality of life by evaluating stress levels and sleep patterns, as recorded in PI adapted GSAS Score.)
研究者
Dr Mandar Vijay Doiphode
Punawale Multispeciality Hospital