| CTRI Number |
CTRI/2025/03/081892 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
EFFECTIVENESS OF CHITRAKAGRANTHIKADI KASHAYA AND TRIKANTAKA PAYA IN THE MANAGEMENT OF FUNCTIONAL CONSTIPATION IN THE GERIATRIC AGE GROUP |
|
Scientific Title of Study
|
A Comparative Study to Evaluate The Efficacy of Chitrakagranthikadi Kashaya And Trikantaka Paya 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 Pankaja K |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital,Mysore |
| Address |
Department of Swasthavritta and Yoga,Government Ayurveda Medical College and Hospital,Visvesvaraya circle,Devaraja Mohalla,Mandi Mohalla,Mysore,Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
8618062060 |
| Fax |
|
| Email |
pankajakumar1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkatakrishna K V |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda Medical College and Hospital,Mysore |
| Address |
Department of Swasthavritta and Yoga,Government Ayurveda Medical College and Hospital,Visvesvaraya circle,Devaraja Mohalla,Mandi Mohalla,Mysore,Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9448572614 |
| Fax |
|
| Email |
srisadguru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaja K |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital,Mysore |
| Address |
Department of Swasthavritta and Yoga,Government Ayurveda Medical College and Hospital,Visvesvaraya circle,Devaraja Mohalla,Mandi Mohalla,Mysore,Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
8618062060 |
| Fax |
|
| Email |
pankajakumar1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital,Visvesvaraya circle,Devaraja Mohalla,Mandi Mohalla,Mysore,Karnataka,570001 |
|
|
Primary Sponsor
|
| Name |
Dr Pankaja K |
| Address |
Government Ayurveda Medical College and Hospital,Visvesvaraya circle,Devaraja Mohalla,Mandi Mohalla,Mysore,Karnataka,570001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaja K |
Government Ayurveda Medical College and Hospital,Mysuru |
OPD room no 12,Department of Swasthavritta and Yoga,Government Ayurveda Medical College and Hospital,Visvesvaraya circle,Devaraja Mohalla,Mandi Mohalla,Mysore,Karnataka,570001
Mysore
KARNATAKA |
8618062060
pankajakumar1997@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,Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakagranthikadi Kashaya, Reference: Ashtanga hridaya Chikitsa sthana 14/48, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Prakshepaka dravya Vida lavana Saindava lavana and Hingu | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: TRIKANTAKA PAYA, Reference: SARANGADARA SAMHITA MADHYAMA KHANDA 2/163, Route: Oral, Dosage Form: Ksheerpaka, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with stool form score of 1 or 2 according to the Bristol stool form scale
Subjects belonging to ROME IV diagnostic criteria |
|
| ExclusionCriteria |
| Details |
Subjects with already diagnosed structural gastrointestinal disorders causing constipation
Subjects with secondary constipation due to surgeries
Subjects with already diagnosed chronic systemic diseases
Subjects who have lactose intolerance |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of Chitrakagranthikadi kashaya in the management of vibandha in geriatric age group
Effect of Trikantaka paya in the management of vibandha in geriatric age group |
15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the efficacy of Chitrakagranthikadi kashaya and Trikantaka paya in the management of Vibandha in geriatric age group |
15th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
29/03/2025 |
| 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="6"
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 symptom among elderly people.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, and sensation of anorectal blockage, incomplete evacuation, abdominal discomfort and bloating. Functional constipation (FC) refers to constipation without an organic etiology. The pooled prevalence of functional constipation is 10·1 percent (range of 8·6–11·6) when Rome IV criteria were used.. When geriatric age group is considered, they have physiological dominance of Vata because of ageing which may contribute to manifestation of vibandha in old age. So, administration of snigdha, vatashamana and vibandhahara dravya is very much essential. Thus, an attempt is made to assess and compare the efficacy of Chitrakagranthikadi kashaya & Trikantaka paya in the management of Vibandha in geriatric age group. |