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临床试验/CTRI/2024/10/075774
CTRI/2024/10/075774尚未招募2/3 期

Randomized controlled clinical trial to evaluate the efficacy of Abhayadi Leha in the management of Amlapitta(Hyperacidity).

C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月24日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Avipaka (Suffering from Indigestion) Klama (Fatigue) Utklesh(Nausea) Tikta Udgar (Bitter belching) this Lakshanas wi

研究概览

简要总结

Amlapitta has become one of the common problem in present era due to change in lifestyle. It is a pitta dosha dushti disease of the Annavaha strotas (Digestive System) caused due to mandagni (Poor Apetite) and Ama. Amlapitta is mentioned by laghutrayee. At around 700 A.D Madhavakar describes amlapitta vyadhi separately in Madhavnidan.

Amlapitta also mentioned by Yogaratnakar, Bhaishjyaratnavali, Rasaratnasamuchhaya etc. According to Charak Samhita in Grahani Adhyaya (Cholitis Chapter) finds similar and identical symptoms of Amlapitta in the purva rupa (Pre Symptoms) named under the term Shukta paka. Amlapitta may be caused due to excessive intake of oily, spicy, tinned, frozen, half cooked food, fast food, irregular meal patterns, habits like alcohol, smoking and psychological stress. i.e. Hurry, Worry and Curry have to avoid.

Vitiation of agni is the main pathophysiological factor in all diseases. Amlapitta is the disease describe thoroughly by Madhava. Amlapitta caused due to mandagni the ingested food undergoes Vidagadpaka, & then the pachaka pitta attains excessive amlata & causes vidaha.

Due to urbanization, changed lifestyle and dietary incompatibility Amlapitta has became a common problem in the society..The prevalence of rate of Amlapitta is observed about 32%. It affects the quality of life and sometime though it is not life hindering but still it affects ones day to day life. Many studies have been done in this context but still it is a common prevalent problem. Many of individuals are suffering from Amlapitta. To avoid further complications, Amlapitta have to treat in early stages. Almost all available antacid drugs are liable to have side effects on body.

Null Hypothesis :There is no significant role of ABHAYADI LEHA in management of Amlapitta.

Alternative Hypothesis : There is significant role of ABHAYADI LEHA in management of Amlapitta.

The study will be conducted on 100 patients with 50 patients of trial group will be treated with Abhayadi leha and the other 50 patients of Control group will be treated with Avipattikar Churna and the result will be conducted.

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
20.00 Year(s) 至 45.00 Year(s)(—)

入选标准

  • Male / Female. 2) Age.
  • 20 years to 45 years. 3) Patient having clinical signs and symptoms of Amlapitta as described in Madhava Nidan. Ref. (Madhav Nidan 34/2,3)(20) • Avipaka (Suffering from Indigestion) • Klama (Fatigue) • Utklesh(Nausea) • Tikta Udgar (Bitter belching) • Amla Udgar (Sour belching) • Hruddah (Heartburn) • Kanthadaha (Burning sensation in throat) • Aruchi (Disliking of food) 4) Chronicity less than 1 year.

排除标准

  • Patients with diagnosed cases of gastric, peptic and duodenal ulcers.
  • Patients with any GIT, abdominal complications and chronic illness.
  • Patients with diagnosed cases of any systemic disorder.
  • Pregnant and lactating women.

结局指标

主要结局

Avipaka (Suffering from Indigestion) Klama (Fatigue) Utklesh(Nausea) Tikta Udgar (Bitter belching) this Lakshanas wi

时间窗: 14 days

ll be decreased.

时间窗: 14 days

次要结局

  • Amla Udgar (Sour belching) Hruddah (Heartburn) Kanthadaha (Burning sensation in throat) Aruchi (Disliking of food) this Lakshanas will be decreased.

研究者

发起方
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Krushna Vijay Hamand

C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya

研究点 (1)

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