Efficacy of whole system approach Ayurveda interventions in Vibhanda W.S.R Oldage Constipation - A Randomized Control Clinical Trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Whole system approach will give significant result in the management of vibandha (old age constipation)
Study Overview
Brief Summary
Title of the Research Project: Efficacy Of Whole System Approach Ayurveda Interventions In Vibhanda W.S.R Oldage Constipation - A Randomized Control Clinical Trial
Summary of the proposed research
Constipation is a common gastrointestinal complaint in apparently healthy population as well as in patients with various predisposing disorders with approximately 12 to 19% global prevalence.The prevalence of constipation rises dramatically with age, with some estimates approaching 50% among adults over 80 years of age. Up to 40% of seniors living in the community and 60% of those in institutions are affected. Lower socioeconomic class, non-white race, regular medication use, female sex, and symptoms of anxiety and depression have all been associated with increased prevalence of constipation among older people.Thehigh prevalence rate, economic burden and adverse implications on the quality of life makes constipation a major public health issue.Functional constipation is the most common form of constipation. The “Rome III criteria†is a widely accepted for diagnosis of Functional constipation.
Vibandha is a clinical condition which is especially bounded in the intestine and characterized by pain in abdomen, dry stools, indigestion etc hence, it is correlated to constipation. Today in contemporary science many of the established Treatment options are available with their own limitation.
It is evident from WHO report that more than 80% of world population especially in developing countries dependent on herbal medicine. A large number of herbs/formulations have been mentioned for the treatment of vibandha. In ayurveda the preparations are given based on Kostha assesment hence the Whole system approach is necessary to prescribe the suitable drugs to patients. . Hence this study has been undertaken to evaluate the efficacy of Whole system approach in the management of Vibandha.
Anticipated Outcome–
1) Whole system approach will give significant result in the management of vibandha (old age constipation)
2) Improving the patient Quality of life in old age
Previous Published research article by Our department PG Scholar on Kalyanaka kshara.
1) Gupta SB, Shindhe PS, Hiremath R R. Evaluation of effect of kalyanaka kshara in vibandha with special reference to constipation: An open clinical trial. Indian J Health Sci Biomed Res 2019;12:44-9
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 60.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients fulfilling the “Rome III diagnostic criteria for functional constipationâ€.
- •2.Age – 60 to 80 years of either sex.
Exclusion Criteria
- •1.Patients on chronic laxative medication (>60 days) and/or who are on medications known to cause constipation (like Opioid analgesics, Antidepressants,i.e. Amitriptyline and Imipramine, Anticonvulsants and Aluminum-containing antacids).
- •2.Those with functional gastrointestinal disorders other than Functional constipation (i.e., IBS, mucous colitis, crohn’s disease, Belching disorders, etc.) 3.Patients with a history of abdominal or anorectal surgery in the past one year and H/O those uncontrolled systemic ailments (like HIV, Diabetes mellitus, and Tuberculosis) and neurological conditions (like Parkinson’s disease and Paraplegia or Autonomic neuropathy) will be excluded.
Outcomes
Primary Outcomes
Whole system approach will give significant result in the management of vibandha (old age constipation)
Time Frame: After two years
Secondary Outcomes
- Improvement in the Patient Quality of life(Assessed after intervention)