| CTRI Number |
CTRI/2025/03/081729 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To Compare The Effect Of Yava Amalaki Peya And Vaiswanara Churna In The Management Of Constipation In Old Age People |
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Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF YAVA AMALAKI PEYA AND VAISHWANARA CHURNA IN THE MANAGEMENT OF VIBANDHA VIS A VIS FUNCTIONAL CONSTIPATION IN GERIATRIC AGE GROUP
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmipriya S |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College Mysuru |
| Address |
Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital Vishweshwarayya circle New Sayyaji Rao Road Devaraja mohalla Mandimohalla Mysuru
Mysore KARNATAKA 570001 India |
| Phone |
9916227669 |
| Fax |
|
| Email |
drlakshmipriya2020@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Venkatakrishna K V |
| Designation |
Professor and Head of the department |
| Affiliation |
Government Ayurveda Medical College Mysuru |
| Address |
Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital Vishweshwarayya circle New Sayyaji Rao Road Devaraja mohalla Mandimohalla Mysuru
Mysore KARNATAKA 570001 India |
| Phone |
9448572614 |
| Fax |
|
| Email |
srisadguru@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Lakshmipriya S |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College Mysuru |
| Address |
Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital Vishweshwarayya circle New Sayyaji Rao Road Devaraja mohalla Mandimohalla Mysuru
Mysore KARNATAKA 570001 India |
| Phone |
9916227669 |
| Fax |
|
| Email |
drlakshmipriya2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital Vishweshwarayya circle New Sayyaji Rao Road Devaraja mohalla Mandimohalla Mysuru Karnataka State
Pincode 570001
India |
|
|
Primary Sponsor
|
| Name |
Dr Lakshmipriya S |
| Address |
Government Ayurveda Medical College and Hospital Vishweshwarayya circle New Sayyaji Rao Road Devaraja mohalla Mandimohalla Mysuru
Karnataka State
Pincode 570001 India |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lakshmipriya S |
Government Ayurveda Medical College Mysuru |
OPD Room 12 Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital Vishweshwarayya circle New Sayyaji Rao Road Devaraja mohalla Mandimohalla Mysuru
Karnataka State Pincode 570001 India Mysore KARNATAKA |
9916227669
drlakshmipriya2020@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Government Ayurveda Medical College and Hospital Mysuru |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: VIBANDHA, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: -, Ritucarya: -, Acara Rasayana:-, Other:-, Pathya/Apathya:yes, Pathya:200ml of Yava amalaki peya will be advised in morning in empty stomach for 14 days , Apathya:- | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vaiswanara Churna, Reference: Sahasrayoga Churna Prakarana 86th Yoga , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Ghee), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vaishwanara churna , Reference: Sahasrayoga Churna Prakarana 86th Yoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: yava amalaki peya ( morning in empty stomach- dose-200 ml) along with vaiswanara churna with ghritha (afternoon and night before food) will be advised for 14 days |
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Inclusion Criteria
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| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 subjects of age group 60 to 75 years of age irrespective of caste religion and gender will be selected
2 Subjects with a stool form score of 1 or 2 according to Bristol stool form scale will be included
3 subject belonging to ROME IV diagnostic criteria will be included
|
|
| ExclusionCriteria |
| Details |
1 Subjects with already diagnosed structural gastrointestinal disorders causing constipation will be excluded
2 Secondary constipation due to surgeries will be excluded
3 Subjects with already diagnosed chronic systemic diseases will be excluded
|
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1 Changes in Bristol stool scale in geriatric age group before and after taking Yava amalaki peya
2 Changes in Bristol stool scale in geriatric age group before and after taking Vaishwanara churna
3 Changes in Bristol stool scale in geriatric age group before and after taking Yava amalaki peya and vaishwanara churna
4 Comparing the outcomes |
14 Days of intervention
Assessment on 15th day and 31st day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To assess the quality of life in geriatric population with functional constipation
|
14 Days |
|
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Target Sample Size
|
Total Sample Size="63" Sample Size from India="63"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
25/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Constipation is a common gastrointestinal problem in the elderly. The incidence of constipation increases with advancing age, particularly after 60 years of age. Constipation is defined as infrequent passage of stools or difficulty with evacuation of stools. It is associated with various symptoms including hard stools, straining, sensation of anorectal blockage, incomplete evacuation, abdominal discomfort and bloating. This even affects the quality of life. Functional constipation (FC) refers to constipation without an organic etiology. The pooled prevalence of functional constipation is10.1% (range of 8.6–11.6) when Rome IV criteria were used. Drugs such as bulk-forming agents, stimulants, stool softeners, osmotic agents and secretagogues are used depending on the chronicity and severity of the condition. Evidence supporting the use of bulk agents, stool softeners, stimulants, and prokinetic agents are lacking, limited or inconsistent. Moreover, it may create side effects like bloating, headache, vomiting, loss of haustral folds in the colon etc in long-term. In Ayurveda terms like vibanda, malagraha, malabaddhata, malavarodha, varchagraha can be correlated with constipation. When geriatric age group is considered, indefinite diet pattern, irregularities in agni as well as predominance of ruksha guna of vata results in vibandha. So, administration of snigdha, agnideepana and vatashamana diet is very much essential. Vaiswanara churna with ghrita anupana having properties of Deepana, vibandagna and vatanulomana will help in reducing vibanda. Yava amalaki peya with yava, amalaki, pippali and ghritha as ingredients is having Snehana, Deepana, Vatanasana, Doshanulomana and Purishajanana properties may help in managing vibandha. This will be a cost effective and easily prepared recipe which can be given as diet in management of vibandha in geriatric population. |