跳至主要内容
临床试验/CTRI/2025/02/081049
CTRI/2025/02/081049尚未招募2 期

Open label single arm clinical study to evaluate the effectiveness of Pittaghna Kala Basti in the management of Chirotha Amlapitta.

SDM College of Ayurveda and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月18日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Assessment will be based on Samyak Basti Lakshanas, Retention time of Basti Dravya, and Number of Vegas for the procedure; and Avipaka (indigestion), Utklesha(nausea), Tikta-amla udgara (spicy-sour belching), Hrit-kantha daha (burning sensation in chest and throat) and Epigastric tenderness are to be assessed for Chirotha Amlapitta.

研究概览

简要总结

Amlapitta is one of the commonest prevalent diseases in society, primarily influenced by factors such as poor dietary habits, lifestyle changes, poor maintenance of food timings and prolonged medication. It predominantly affects younger and middle-aged individuals, with a prevalence rate of 78.8% in the general population, notably 48.9% for acute cases and 29,9% for chronic cases’. In India, 3 in 869 individuals are suffering from the disease .77.2% among them are adult aged 19 to 26 years. Despite the abundance of available treatments in all medical systems, none can fully cure the condition, leading to recurrent symptoms and dependence on medications, often proceeds to chronic Amlapitta. This highlights the need for effective preventive measures. Hence, the disease is being chosen for the study.

Basti stands out as the premier treatment for Vata disorders, but its efficacy extends equally to Pitta, Kapha, and Rakta imbalances. Specifically addressing Pitta imbalances, Charaka recommends the administration of five to six Anuvasana Basti. Even though Basti exits the intestine quickly, the potency of the medications still spreads throughout the interneurons of the gut, exerting an impact on the enteric nervous system. Notably, he emphasizes the use of Pittaghna Basti formulations, which possess qualities such as Tikta. Madhura Rasa. Snigdha and Sheeta Basti treatment is given the higher prevalence of chronic cases, there’s a significant focus on addressing them. Specifically, for Chirotha Amla Pitta Asthapana and Anuvasana Bastis are recommended. Hence, Pittaghna Basti may be effective in alleviating the condition.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • Chronicity more than 6 months
  • Age group hetween 18-60 years either gender
  • Participants fit for Basti Karma
  • Participants who are willing to participate and sign the informed consent form.

排除标准

  • Pregnant women
  • Patients with history of systemic illness like diabetic mellitus and uncontrolled hypertension, immunodeficiency disorders like AIDS, and Carcinoma
  • Patients with Renal diseases, heart diseases, known case of hiatus hernia.

结局指标

主要结局

Assessment will be based on Samyak Basti Lakshanas, Retention time of Basti Dravya, and Number of Vegas for the procedure; and Avipaka (indigestion), Utklesha(nausea), Tikta-amla udgara (spicy-sour belching), Hrit-kantha daha (burning sensation in chest and throat) and Epigastric tenderness are to be assessed for Chirotha Amlapitta.

时间窗: 10days

次要结局

  • Improvement in ease of lifestyle(25days)

研究者

发起方
SDM College of Ayurveda and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Mohana Sundarai M

Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital

研究点 (1)

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