A randomised standard controlled clinical study to evaluate the effectiveness of Drakshadi Gutika in the management of Amlapitta
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- 1.To compare the efficacy of Drakshadi Gutika 500 mg 1 tablet two times a day after meal with normal water and Guddi Modak 500 mg 1 tablet two times a day after meal with normal water in amlapitta for 21 days.
研究概览
简要总结
The physiology of the gastrointestinal tract is disturbed in the
current period of rapidly changing lifestyles as a result of an
irregular meal schedule, lack of exercise, lack of sleep, poor eating
habits, and mental stress, which impairs Agni. Agni’s impairment
results in Agnimandya.
As described in Ayurveda,
रोगा: सरà¥à¤µà¥‡à¤…पि मनà¥à¤¦à¥‡sगà¥à¤¨à¥Œ ।
अ.हà¥à¤°.नि.12/1
Agnimandya is the root cause of all the diseases. Agnimandya
causes indigestion of food.
This indigested food further leads to “Amlapittaâ€.
The word "amla" describes a certain flavour that is associated with
sourness and causes excessive salivary secretions. Pitta is a
biological chemical component that is mainly responsible for the
maintenance of the process of digestion and transformation.
Pitta dosha vitiation in the body is a pathological disease known as
amlapitta.
Pitta dosha possesses Katu rasa but when it becomes vitiated, it
transforms into Amla rasa.
After consumption of avirodhi, dushta bhojan, pittaprakopak aahar
pitta dosha present in our body exaggerated and becomes vidagdha
and causes symptoms like Hrullas (Nausea), TiktaAmlodgar (sour
and bitter blenching), Gaurava (feeling of heaviness in the body),
Hrit-Kantha daha (heart and throat burn), Aruchi (anorexia),
shirashul (Headache) evident clinically.
Ayurveda follows a holistic approach towards Amlapitta.
Ayurveda concentrate more on Agni Vriddhi and Aam Pachan by
various means. Having said this, there is a need for treatment which
can prevent complications of the disease, improve digestion,
relieves symptoms, cost-effective and easily available.
Drakshadi Gutika is mentioned in Yogratnakar for treatment of
Amlapitta. The ingredients present in this drug are Draksha, Haritaki,
Mishri.
These drugs shows an antagonistic action on the Prakupit Doshas
involved in Amlapitta. Therefore, this Kalpa is proposed to show an
efficient action on the pathology of the disease.Hence this drug is
used as a trial drug
In the previous study, Gudadi Modak was found to be significant in
the management of Amlapitta, therefore for the present study
Gudadi Modak will be taken as a control group.
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
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are having at least 1 or more cardinal signs and symptoms of Amlapitta described in Madhav nidan Cardinal Symptoms – Hrullas (Nausea), Hrit-Kanthadaha (Heart burn), Shirashul (Headache) Tiktamla Udgara(acid eructation).
排除标准
- •1.The Known case of gastric ulcer, duodenal ulcer, stomach cancer, cancer of esophagus, esophageal varices, hematemesis.
- •Patients with long term use of painkiller & steroids.
- •Severe malnourished patient 4.pregnant and lactating women.
结局指标
主要结局
1.To compare the efficacy of Drakshadi Gutika 500 mg 1 tablet two times a day after meal with normal water and Guddi Modak 500 mg 1 tablet two times a day after meal with normal water in amlapitta for 21 days.
时间窗: 21 days study with 3 followups on 7th, 14th and 21st day
2. To give maximum symptomatic relief to patients after 21 days.
时间窗: 21 days study with 3 followups on 7th, 14th and 21st day
3. Relief from Tiktamla udhar, hritkanth daha, shirashul, hrullas.
时间窗: 21 days study with 3 followups on 7th, 14th and 21st day
次要结局
- to study the adverse drug effects if any(21 days study with 3 followups on 7th, 14th and 21st day)
研究者
Dr Rupali Bandu Naik
PDEAs college of ayurved and research centre nigdi pune