To evaluate the effect of Laghushankhaprakshalana (LSP) in the management of vataj grahani roga W.S.R Irritable bowel syndrome [IBS]- A comparative randomized controlled open label clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- 75% reduction in signs and symptoms of vataj ggrahani roga as well IBS Severity Score Scale(IBS SSS).
研究概览
简要总结
This research will involve practice of laghushankhprakshalan and the patient visit the hospital in morning once in a week for the practice for three months. Patient will be asked for follow-up in every 2 weeks (visit to collect the drug) This is one of the common clinical problems among patients attending gastroenterology clinics. The main clinical features of this ailment are abdominal pain associated with an altered bowel habit (may present with diarrhea or constipation or intermittently both) in the absence of any structural pathology. And the management of this disease is having limitations in the present scenario of the contemporary science. Ayurveda has solutions for lifestyle functional disorders like irritable bowel syndrome. In the beginning of last century, influenced by the developments in modern medicine, some Ayurvedic experts attempted to enrich Ayurveda without losing its basic concepts. after doing Shankha Prakshalana one feels very light and also a sense of rejuvenation in the body, whereas after taking the purgatives a feeling of heaviness, weakness and dullness in the body occurs.
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 50.00 Year(s)（—）
入选标准
- •ICD-11 Irritable bowel syndrome, constipation predominant (DD91.00) Irritable bowel syndrome, diarrhoea predominant (DD91.01) Irritable bowel syndrome, mixed type (DD91.02) Irritable bowel syndrome, unsubtyped (DD91.03) Irritable bowel syndrome, type unspecified (DD91.0Z) Age: 18-50 years Gender-both males & females.
- •Patients having pratyatma lakshana of Grahani Roga especially –Atisrushtam malapravritti, Ativibadhham malapravritti, Atidravam malapravritti, Udara Shula (pain in abdomen), Anaha (distention of abdomen), Mala Tyaga Asantushti (dissatisfaction after defecation), Kapha Nihssarana (mucus in stool), Udara Atopa (tympanitis), Bhojanopranta Mala Tyaga (defecation after taking meals), Shuktpaka, Mana sadnam, Kruchapaka, Alteration of bowel habit (Shushka, Tanu, Apkwa, Phenyukta Malapravrutti)& The patients who are diagnosed with IBS according to standard ROME IV criteria.
- •Patient with symptom onset at least 6 months prior to diagnosis.
- •Willing to give written informed consent.
排除标准
- •Previously diagnosed cases and history of Ulcerative colitis, Crohn’s disease, gastric ulcerations, Intestinal tuberculosis and other inflammatory bowel conditions.
- •Mixed infection with parasites such as round worms, hook worms, & lactose intolerance patients.
- •Patients with evidence of malignancy.
- •Patients with Diabetes Mellitus.
- •Patient with poorly controlled Hypertension Abuse of drug or alcohol.
- •Presence of other somatic or mental disorder requiring medication.
- •Patients on prolonged medication with NSAIDs, analgesics or any other drugs that may have an influence on the outcome of the study.
- •Pregnant & lactating women.
- •Systemic disorders like respiratory, cardiac, renal, nervous, Degenerative disorders BMI above 40.
结局指标
主要结局
75% reduction in signs and symptoms of vataj ggrahani roga as well IBS Severity Score Scale(IBS SSS).
时间窗: At Baseline, 14th day-28th day-42nd day-56th | day-70th day-84th day and at the end of follow | up after 18th week
次要结局
- Overall improvement in the quality of life(At Baseline, 14th day-28th day-42nd day-56th)
研究者
Dr Nikhil Sharma
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India