Efficacy and safety of kosthasuddhikriya versus Prucalopride in patients with functional constipation: a pilot non-inferiority randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To determine and compare the efficacy of Kosthasuddhikriya (KSK) with Prucalopride for treatment of Functional Constipation in terms of Complete spontaneous bowel movement per week (CSBM) and Bristol stool form scale (BSFS).
研究概览
简要总结
YOGIC(Yoga In Constipation) trial is a Randomized controlled parallel group single blinded study design to determine the safety and efficacy of Kosthasuddhikriya (KSK) as compared to Prucalopride for the treatment of functional constipation. KSK is a yogic technique designed and created combining sequential set of specific Yoga asanas like: Tadasana, tiryaka tadasana, kati chakrasana, tiryak bhujangasana, udarakarshanasana, mandukasana and drinking 400 ml of luke warm water in malasana. KSK is a modified form of Sankshaprakhalana (SP) which is an yogic technique used for bowel cleansing in ancient Indian science. Recently few studies on role of SP in Bowel preparation and cleansing prior colonoscopy published in Indian journal of gastroenterology. However, no study till date has explored therapeutic role of yoga in constipation as for best of our knowledge. In this trial patient diagnosed to have functional constipation as per rome IV crteria will undergo screening and baseline assessment followed by 1:1 Randomization will be done into two study arms using a sealed envelope concealment method (computer generated) investigator will be blinded during study allocation. After randomization each participant will be provided a bowel health dairy for recording of their parameters, symptoms and yoga teaching will be done by YOGA instructors and recorded KSK Yoga videos will be provided for subsequent use to Yoga arm participants and Prucalopride 2 mg Tablet will be provided to Prucalopride arm. Biscodyl 5 mg tablet will be provided to each group as a rescue therapy. Efficacy Outcome assessment will be in terms of Complete spontaneous bowel movement score and Change in bristol stool form scale(BSFS) Score. Secondary out comes will be assessed in terms of various symptom score(meausred in likert scale) . Acceptability and safety will be assessed by a pre validated questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and non-pregnant female subjects (18-65 years of age) with clinical diagnosis of functional constipation (As per ROME IV criteria) with BMI of 18-35 Kg/m2 will be included in the trial, Willing to comply with protocol requirements and sign a statement of informed consent, Willing to stop any laxatives used before the Pretreatment period in favor of the protocol-defined Rescue Medicine (bisacodyl tablets or suppositories),Agree to abstain from making any fresh, significant lifestyle adjustments that might impact symptoms (such as altering their workout regimen or nutrition) between the time the ICF was signed and the final trial visit.
排除标准
- •age less than 18 and more than 65 with significant comorbidity like uncontrolled diabetes, uncontrolled hypertension secondary Constipation due other disease or drug, IBD, past GI surgery, Pregnant and lactating mothers, People with HCV/HBV/HIV seropositive, not willing to give consent, not able to perform KSK asana due to muskuloskeletal disoredes will be excluded.
结局指标
主要结局
To determine and compare the efficacy of Kosthasuddhikriya (KSK) with Prucalopride for treatment of Functional Constipation in terms of Complete spontaneous bowel movement per week (CSBM) and Bristol stool form scale (BSFS).
时间窗: At baseline, 4 WEEKS, 8 WEEKS
次要结局
- To determine the efficacy of KSK for treatment of patients with Functional constipation in terms of various GI symptom scores Change in average weekly Abdominal pain/bloating/straining/sense of incomplete evacuation scores.(At 2,4,6,8 week of intervention)
- To evaluate the safety and acceptability of KSK as a treatment of patients with Functional constipation.(At 8 week)
- To determine the proportion of patients requiring rescue treatment in both study arms.(At 8 week of intervention)
研究者
Manas Kumar Panigrahi
AIIMS, Bhubaneswar