跳至主要内容
临床试验/CTRI/2025/01/078850
CTRI/2025/01/078850已完成Phase 3 4

To Compare the Efficacy of Patoladi Kwath with Patoladi Kwath Ghan Vati in Amlapitta wsr Acid Peptic Disorder - A Randomized Controlled Trial

Ch Brahm Prakash Ayurved Charak Sansthan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月23日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Hritdaha (Heart Burn)

研究概览

简要总结

Amlapitta can be correlated with acid peptic disorder. Amlapitta is a condition in the upper gastrointestinal tract caused by abnormal Pittapathological conditions. It involves an increase in Pachak pitta and a change in Pitta’s bitter taste to a sour taste. According to Acharya Kashyapa, Nidana sevana causes Doshaprakopa, particularly of Pitta Dosh, which creates Mandagni, which in turn creates VidagdhaandShuktibhava in food, leading to Amlata in Amashaya. The first and foremost group of etiological factors of Amlapitta may be considered a dietary factor. Acharya Sushruta has mentioned a symptom known as Amlika, which results from excessive use of Lavana rasa and is similar to Amlapitta (acid peptic disorder). Common symptoms include heartburn, regurgitation, dysphagia, altered appetite, satiety, vomiting, nausea, and epigastric pain. Gastric juices contain pepsin and hydrochloric acid, breaking down proteins into peptides and peptones. The stomach’s filling and emptying activities are regulated by signals from the stomach and duodenum, with factors like enterogastrin inhibiting emptying. The stomach wall is impermeable to most substances, preventing absorption until the small intestine. However, some substances, like water, ions, drugs, and alcohol, are absorbed. Antacids, proton pump inhibitors (PPI), and H2 inhibitors are commonly used medicines to neutralize stomach acid and relieve symptoms. However, their widespread use has led to long-term adverse effects, including increased risk of kidney, liver, and cardiovascular disease, dementia, gastrointestinal tract tumours, susceptibility to infections, and impaired nutrient absorption. Long-term use also causes rebound acid production, abdominal pain, nausea, osteopenia, and constipation. The present study aims to evaluate the role of Patoladi Kwath and Patoladi Kwath Ghan Vati in improving symptoms of Amlapitta. The total number of patients is 80, 40 in each group. In group A, Patoladi Kwath will be administered a dose of 40 mL twice a day with lukewarm water on an empty stomach. In group B, Patoladi Kwath Ghan Vati is administered in a dose of 2 tablets, 500 mg each, twice a day with lukewarm water after food. The study design is a single-centred, open-labelled, randomized, comparative, interventional study.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Any one or more clinical features of Amlapitta as described in Ayurvedic texts viz Amlodgaar Tiktodgaar Kantha daah Urah daah Aruchi Utklesha Avipaka Gaurav Klama and Shiroruk for more than one month and up to 2 years
  • Subjects of Age group between 21 to 60 years
  • Subjects not having any other serious illness
  • Subject willing to participate in the study and ready to give informed consent
  • Subjects not registered in any other research projects.

排除标准

  • Age group less than 21 years and more than 60 years
  • Known cases of Gastric and Duodenal ulcers and gastric carcinoma
  • Pregnant or lactating women
  • Subjects taking NSAID & whom the investigators judge to be unsuitable to participate in the clinical trial (diagnosed psychotic illnesses, substance dependence, or alcoholism).
  • Subjects with major systemic illnesses, including cardiac disease, liver disease, kidney disease, uncontrolled diabetes, uncontrolled hypertension, inflammatory bowel disease, psychoneuroendocrinal disorders, etc.

结局指标

主要结局

Hritdaha (Heart Burn)

时间窗: 30 days

Improvement in symptom severity of Amlapitta (Acid peptic disorder)

时间窗: 30 days

Avipaka (Indigestion)

时间窗: 30 days

Tiktaudgara (Bitter eructation)

时间窗: 30 days

Kantha daha (Burning in throat)

时间窗: 30 days

Gaurav (Heaviness in body)

时间窗: 30 days

Utklesa (Nausea)

时间窗: 30 days

Klama (Lassiitude)

时间窗: 30 days

Aruchi (Loss of appetite)

时间窗: 30 days

Amlaudgara (Sour eructation)

时间窗: 30 days

Shiroruk (Headache)

时间窗: 30 days

次要结局

未报告次要终点

研究者

发起方
Ch Brahm Prakash Ayurved Charak Sansthan
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Kanika Aggarwal

Ch Brahm Prakash Ayurved Charak Sansthan

研究点 (1)

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