A Pre and Post Test Clinical Study to Evaluate the Effectiveness Of GrahaniTreatment Protocol on Gut Microbiota Flora in IBS- Mixed
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1. Bristol Stool Form Scale (BSF)
研究概览
简要总结
10 patients fulfilling the inclusion and exclusion criteria, who are voluntarily ready to participate will be selected from the OPD and IPD of Post-Graduate Department of Kayachikitsa, Amrita Ayurveda Hospital. For Pachana-Deepana, 50 ml of Vacharidradi Kashaya twice daily before food will be given for 3-7 days or till the attainment of Samyak Langhita Lakshanas, whichever is seen earlier. Then the patient will be subjected to Sadya Snehapana with Dadimadi Ghrita for 3 days. For the next 3 days the patient will be subjected to Sarvanga Abhyanga with Tila Taila and Bashpa Sweda. Virechana with Avipatti Churna along with Honey will be administered after Sarvanga Abhyanga Bashpa Sweda. This will be followed by Samsarjana Karma according to the Koshta Suddhi. After Virechana, Shamana Oushadha will be administered for the next 30 days with 6 grams of Priyanguambashtadhi churna along with Takra twice daily, orally before food. Post treatment assessment will be done after 30 days of Shamana Oushadha Prayoga by using Bristol stool form scale, IBS-SSS(symptom severity scale), VAS (visual anolog scale), IBS- Qol (quality of life scale) and Assessment of Gut Microbiota in stool sample. The data collected will be statistically evaluated
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants fulfilling ROME IV CRITERIA
- •45 years with no discrimination of sex, caste, religion and economic status
- •Patients identified with the presence of specific strains of Lactobacilli and Bifidobacteria from their fecal samples.
- •Participants from whom the written consent is obtained.
排除标准
- •Those with the endoscopic findings of peptic ulcer or any organic lesions and other systemic disorders
- •Those on NSAID’s in the last six months, antibiotics or other long-term and continuous medication
- •Patients with alcohol dependency or drug dependency.
- •Pregnant women and lactating mothers.
结局指标
主要结局
1. Bristol Stool Form Scale (BSF)
时间窗: 1. Before intervention 0th day | 2. After intervention approximately on 50th day
2. VAS (Visual Analog Scale)
时间窗: 1. Before intervention 0th day | 2. After intervention approximately on 50th day
3. IBS- SSS (Symptom Rating Scale)
时间窗: 1. Before intervention 0th day | 2. After intervention approximately on 50th day
4. IBS- QoL (Quality of Life) Questionnaire
时间窗: 1. Before intervention 0th day | 2. After intervention approximately on 50th day
5. Assessment of the Gut Microbiota in the Stool sample (Before and after treatment)
时间窗: 1. Before intervention 0th day | 2. After intervention approximately on 50th day
次要结局
- Not Applicable(Not Applicable)