| CTRI Number |
CTRI/2019/09/021220 [Registered on: 12/09/2019] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Whole system approach Ayurveda interventions in the management of Oldage Constipation |
|
Scientific Title of Study
|
Efficacy of whole system approach Ayurveda interventions in Vibhanda W.S.R Oldage Constipation - A Randomized Control Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh S Killedar |
| Designation |
Assistant Professor |
| Affiliation |
KAHERs Shri B. M. Kankanwadi Ayurveda Mahavidyalaya, Shahpur, Belagavi |
| Address |
Assistant Professor, Dept of Shalyatantra, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya, Shahpur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9035987505 |
| Fax |
|
| Email |
drramesh39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh S Killedar |
| Designation |
Assistant Professor |
| Affiliation |
KAHERs Shri B. M. Kankanwadi Ayurveda Mahavidyalaya, Shahpur, Belagavi |
| Address |
Assistant Professor, Dept of Shalyatantra, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya, Shahpur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9035987505 |
| Fax |
|
| Email |
drramesh39@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh S Killedar |
| Designation |
Assistant Professor |
| Affiliation |
KAHERs Shri B. M. Kankanwadi Ayurveda Mahavidyalaya, Shahpur, Belagavi |
| Address |
Assistant Professor, Dept of Shalyatantra, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya, Shahpur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9035987505 |
| Fax |
|
| Email |
drramesh39@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya |
|
|
Primary Sponsor
|
| Name |
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya |
| Address |
Near Nath Pai circle, Shahpur, Belagavi. Pin - 590003 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Killedar |
KAHER’s Shri B M K Ayurveda Mahavidyalaya |
Department of Ayurveda Medical Education / Hospital office
Belgaum
KARNATAKA |
9035987505
drramesh39@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oldage |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1: Kalyanaka kshara
|
Group 1: Kalyanaka kshara
Anupana : with Ghee.
Dose : Patients will be treated with Kalyanaka Kshara 1gm twice a day for 10 days.
|
| Intervention |
Group 2 - whole system Ayurveda approach. |
Group 2 - whole system Ayurveda approach.Oral administration based on Kostha assesment
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling the “Rome III diagnostic criteria for functional constipationâ€.
2.Age – 60 to 80 years of either sex.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Whole system approach will give significant result in the management of vibandha (old age constipation) |
After two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Patient Quality of life |
Assessed after intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2020 |
| Date of Study Completion (India) |
31/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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 |