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临床试验/CTRI/2025/12/098330
CTRI/2025/12/098330招募中2 期

Clinical Study to Evaluate the Effect of Shampakadi Niruha Basti in Grahani w.s.r. to Irritable Bowel Syndrome(IBS).

Dr Yasir Sameer Dabir1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
32
试验地点
1
主要终点
Primary outcomes will include improvement in the clinical features of Grahani.

研究概览

简要总结

Grahani is having NAMC Code ICD-601 EB-7(1) (disorders of lower Gastro Interstinal tract). Grahani is a chronic gastrointestinal disorder described in Ayurveda under the spectrum of Ashta Mahagada (major diseases) by Acharya Vagbhat. It is primarily a dysfunction of Agni (digestive fire), especially Jatharagni, leading to improper digestion and assimilation of food. The seat of Grahani is considered to be the Grahani organ itself, located anatomically near the Amashaya and Pakvashaya, and physiologically responsible for the retention and release of digested food. According to Acharya Charak, Grahani is a disease which is originated from Mandagni (weak digestion), resulting in the formation of Ama (toxic undigested metabolites), which causes symptoms such as Muhur-Baddha Muhur-Drava, Picchila Mala pravrutti, Aruchi, Asyavairasya, Adhman, Antrakujan, Balakshay and Loha-Amagandhi-Tikta-Amla Udgar(2). It can be correlated with conditions such as irritable bowel syndrome (IBS) in modern medicine. The clinical features of Grahani closely resembles to Irritable Bowel Syndrome (IBS) ICD Code- K 58(1), a functional gastrointestinal disorder marked by abdominal pain or discomfort along with altered bowel habits, despite the absence of any detectable structural abnormalities. Since there are no definitive diagnostic tests for IBS, its diagnosis primarily depends on clinical symptoms by GSRS and IBS Score. IBS is among the most frequently observed conditions in medical practice, yet it remains poorly understood. Globally, approximately 10–20% of adolescents and adults exhibit symptoms consistent with IBS, with a higher incidence reported in females. The severity of symptoms may vary widely, often leading to a considerable decline in quality of life and increased healthcare expenses. Current treatment approaches in modern medicine mostly offer symptomatic relief and may sometimes lead to adverse effects. This creates a promising opportunity for Ayurveda as main line of treatment, to explore more effective and holistic treatment options for IBS. Acharya Sushruta mentioned Shampakadi Basti, a type of Asthapan Basti (decoction-based enema), is mentioned in Ayurvedic texts for its Deepana-Pachana, Vata-Kapha shamaka, and Grahani-hara actions. Niruha Basti is considered one of the most effective therapeutic procedures in Panchakarma for Pakvashaya gata Vata and Grahani disorders.

The Study will be consisting of one Group as per the inclusion criteria that group will receive Yoga Basti Krama using Shampakadi Niruha Basti and Murchita Tila Taila Anuvasana Basti for 8 days.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Patients having classical signs and symptoms of Muhur-Baddha Muhur-Drava mala pravrutti, Picchila Malapravrutti, Aruchi, Adhman, Tikta Amlodgar, Antrakujan and Balakshay. Awastha of Grahani in which there is Agnimandya and Purish, Mutra and Maruta Avarodh. Diagnosis with active Irritable Bowel Syndrome symptoms as indicated by a score between (
  • 299 on IBS SEVERITY SCORING SYSTEM) Patient Arha for Basti Karma.

排除标准

  • More than 3 years chronicity of Grahani.
  • Known cases of systemic diseases like Hypertension Cases of Anorectal diseases and Colon Resection Surgeries Patients Anarha for Basti karma Pregnant women and lactating mothers.

结局指标

主要结局

Primary outcomes will include improvement in the clinical features of Grahani.

时间窗: Base Line, 9th Day, 30th Day, 45th Day

Symptom Score Reduction :

时间窗: Base Line, 9th Day, 30th Day, 45th Day

Muhurbaddha Muhurdrava Mala (Episode of hard & loose stools)

时间窗: Base Line, 9th Day, 30th Day, 45th Day

Adhman (Distention of Abdomen)

时间窗: Base Line, 9th Day, 30th Day, 45th Day

Balakshaya (Weakness)

时间窗: Base Line, 9th Day, 30th Day, 45th Day

Picchila Malapravrutti (Passing mucus in stool)

时间窗: Base Line, 9th Day, 30th Day, 45th Day

Aruchi (Anorexia) Tikta-Amlodgara (Iron pungent odour burps)

时间窗: Base Line, 9th Day, 30th Day, 45th Day

Antrakujana (Gurgling sound in abdomen)

时间窗: Base Line, 9th Day, 30th Day, 45th Day

次要结局

  • Secondary assessments may include standardized tools such as the Gastrointestinal Symptoms(Rating Scale (GSRS), IBS Severity Scoring System (IBS-SSS) and Bristol Stool Chart to)

研究者

发起方
Dr Yasir Sameer Dabir
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Yasir Sameer Dabir

College of Ayurved, Bharati Vidyapeeth, Pune

研究点 (1)

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