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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 
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 
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  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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] 
 
Details of Secondary Sponsor  
Name  Address 
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 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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Government Ayurveda Medical College and Hospital Mysuru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: VIBANDHA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--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:-
2Comparator ArmDrugClassical(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: -
3Intervention ArmDrugClassical(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
 
Inclusion Criteria  
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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
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 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the quality of life in geriatric population with functional constipation
 
14 Days 
 
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" 
Phase of Trial   Phase 3 
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 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 

 
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