| CTRI Number |
CTRI/2021/09/036198 [Registered on: 03/09/2021] Trial Registered Prospectively |
| Last Modified On: |
20/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Burden of multiple chronic conditions at AYUSH Primary Care Settings in Delhi- National Capital Territory |
|
Scientific Title of Study
|
Magnitude and Effect of Multimorbidity at AYUSH Primary Care Settings in Delhi- National Capital Territory |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varanasi Roja |
| Designation |
Research Officer,scientist 3, PhD Scholar |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no.315
61-65, Institutional Area
Opp D Block , Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanghamitra Pati |
| Designation |
DIrector |
| Affiliation |
ICMR- Regional Medical Research Centre |
| Address |
ICMR- Regional Medical Research Centre
Chandrasekharpur
Bhubaneswar 3
Odisha, India
South West
DELHI
751023
India |
| Phone |
91-674-2301322 |
| Fax |
|
| Email |
drsanghamitra12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Tandon |
| Designation |
Professor |
| Affiliation |
Amity Institute Of Molecular Medicine And Stem Cell Research |
| Address |
Amity Institute of Molecular Medicine & Stem Cell Research, J-3 108-109
Amity University Campus Sector-125, Noida
Amity Institute of Public Health
Room 214, J-1 Block
Amity University Uttar Pradesh
Amity University Campus Sector-125
Noida-201 303
India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
|
| Fax |
|
| Email |
standon1@amity.edu |
|
|
Source of Monetary or Material Support
|
| Self funded. This study shall be undertaken at AYUSH dispensaries, GOvt. of NCT Delhi |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [nil] |
|
|
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 R K Manchanda |
Dispensaries under Directorate of AYUSH |
Directorate of AYUSH, A and U Tibbia College Campus, Karol Bagh, New Delhi
Central
DELHI |
9811014493
rkmanchanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, (2) ICD-10 Condition: I10-I16||Hypertensive diseases, (3) ICD-10 Condition: M15-M19||Osteoarthritis, (4) ICD-10 Condition: I70-I79||Diseases of arteries, arterioles and capillaries, (5) ICD-10 Condition: N20-N23||Urolithiasis, (6) ICD-10 Condition: K21||Gastro-esophageal reflux disease, (7) ICD-10 Condition: G40||Epilepsy and recurrent seizures, (8) ICD-10 Condition: L20-L30||Dermatitis and eczema, (9) ICD-10 Condition: L80||Vitiligo, (10) ICD-10 Condition: L40||Psoriasis, (11) ICD-10 Condition: M545||Low back pain, (12) ICD-10 Condition: J40-J47||Chronic lower respiratory diseases, (13) ICD-10 Condition: I63||Cerebral infarction, (14) ICD-10 Condition: H53-H54||Visual disturbances and blindness, (15) ICD-10 Condition: H91||Other and unspecified hearing loss, (16) ICD-10 Condition: F03||Unspecified dementia, (17) ICD-10 Condition: F10||Alcohol related disorders, (18) ICD-10 Condition: C00-D49||Neoplasms, (19) ICD-10 Condition: N18||Chronic kidney disease (CKD), (20) ICD-10 Condition: E00-E07||Disorders of thyroid gland, (21) ICD-10 Condition: K58||Irritable bowel syndrome, (22) ICD-10 Condition: K590||Constipation, (23) ICD-10 Condition: F51||Sleep disorders not due to a substance or known physiological condition, (24) ICD-10 Condition: J32||Chronic sinusitis, (25) ICD-10 Condition: G44||Other headache syndromes, (26) ICD-10 Condition: F33||Major depressive disorder, recurrent, (27) ICD-10 Condition: F41||Other anxiety disorders, (28) ICD-10 Condition: M542||Cervicalgia, (29) ICD-10 Condition: D25||Leiomyoma of uterus, (30) ICD-10 Condition: E282||Polycystic ovarian syndrome, (31) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients attending to the sampled AYUSH Primary
care
Adult patients aged 18 years and above attending to outpatient department
giving informed consent |
|
| ExclusionCriteria |
| Details |
Patients too ill to participate, those with insufficient cognitive
ability to complete the questionnaire and those with debilitating physical disabilities and
mental disabilities
not providing informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the pattern of multimorbidity at AYUSH primary level care at Delhi-NCT.
To analyse and compare patterns among different AYUSH systems
To identify the prescription patterns visiting the AYUSH care.
Measure health care utilization and cost of care among multimorbidity patients. |
one time point ,cross sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse and compare patterns among different AYUSH systems
To identify the prescription patterns visiting the AYUSH care.
Measure health care utilization and cost of care among multimorbidity patients. |
one time point ,cross sectional study |
|
|
Target Sample Size
|
Total Sample Size="960"
Sample Size from India="960"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Multimorbidity, is defined as the coexistence of two or more chronic conditions frequently observed in individuals. It can be regarded as an “emergent†health problem and poses a major challenge to health care systems around the world. It is related to ageing but studies have now shown that it is also socially patterned, being more common and occurring at an earlier age in areas of high socioeconomic deprivation. Multimorbidity has a huge challenge to existing institutions, professional authority, and ways of working and in terms of public health. It is the linked problem of polypharmacy, potential drug-drug and drug-disease interactions, and adverse drug reactions (ADRs) other concerning matter is complex management regimens , more frequent and complex interactions with health care services leading to greater susceptibility to failures of care delivery an and coordination. The presence of multimorbidity is associated with increased health service utilization and poorer health outcomes. Objectives To assess the pattern of multimorbidity at AYUSH primary level care at Delhi-NCT To analyse and compare patterns among different AYUSH syste To identify the prescription patterns visiting the AYUSH care.
Measure health care utilization and cost of care among multimorbidity patients |