Clinical Trial On Testing Efficacy & Safety For 2 Siddha Formulations For Functional Constipatio
- Conditions
- Health Condition 1: K590- Constipation
- Registration Number
- CTRI/2019/02/017831
- Lead Sponsor
- Central Council For Research In Siddha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age range between 19 â?? 65 years
2.People meeting the Rome III Diagnostic Criteria
3.Must include two or more of the following:
a.Straining during at least 25% of defecation
b.Lumpy or hard stools in at least 25 % of defecation
c.Sensation of incomplete evacuation for at least 25% of defecation
d.Sensation of ano-rectal obstruction/blockage for at least 25% of defecation
e.Manual maneuvers to facilitate at least 25% of defecation (e.g., digital evacuation, support of the pelvic floor)
f.Fewer than three defecation per week
4.Loose stools are rarely present without the use of laxatives
5.Insufficient criteria for irritable bowel syndrome
6.Patient with stool form score ranging 1-2 Bristol Stool Form Scale
7.People willing to undergo intervention and cooperate with investigations.
1.Patients on Chronic laxative medication ( > 60 day)
2.Medications known to cause constipation
a.Opioid Analgesics
b.Antidepressants
c.Anti Convulsants
d.Aluminium containing Antacids
3.Functional gastro intestinal disorders
a.Belching Disorders
b.Irritable Bowel Syndrome
c.Haemorrhoids
4.H/O Abdominal Surgery in the past 1 year
5.H/O Ano-Rectal Surgery in the past 1 year
6.H/O any Structural Abnormalities in GI tract
7.H/O Chronic DM Medications
8.H/O Chronic HT Medications
9.H/O Renal Dysfunction (KFT Abnormalities)
10.H/O Liver Dysfunction (LFT Abnormalities)
11.H/O Thyroid Disorders and Medications
12.Smoking and alcohol consumption
13.Drug withdrawal within past 6 months
14.H/O Neurological Problems
a.Multiple Sclerosis
b.Parkinsonâ??s Disease
c.Paraplegia
d.Sacral Nerve Damage
15.Lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method