| CTRI Number |
CTRI/2022/04/042309 [Registered on: 29/04/2022] Trial Registered Prospectively |
| Last Modified On: |
28/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
LIPID PROFILE AND ELEVATED URIC ACID IN VATARAKTA (GOUT) |
|
Scientific Title of Study
|
RELATIONSHIP OF LIPID PROFILE AND ELEVATED URIC ACID IN THE CASES OF VATARAKTA (GOUT): AN OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MAHIMA PANDEY |
| Designation |
PG SCHOLAR ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILL BEHIND MANIT ,KOLAR NEHARU NAGAR BYPASS ROAD ,BHOPAL
BHOPAL
MADHYA PARADESH
462003
INDIA
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7879725791 |
| Fax |
|
| Email |
mahimapandey786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY SRIVASTAVA |
| Designation |
PROFESSOR AND HOD OF ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILL BEHIND MANIT ,KOLAR NEHARU NAGAR BYPASS ROAD ,BHOPAL
BHOPAL
MADHYA PARADESH
462003
INDIA
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425012608 |
| Fax |
|
| Email |
sanjayayurvedabhopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAHIMA PANDEY |
| Designation |
PG SCHOLAR , ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILL BEHIND MANIT ,KOLAR NEHARU NAGAR BYPASS ROAD ,BHOPAL
BHOPAL
MADHYA PARADESH
462003
INDIA
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7879725791 |
| Fax |
|
| Email |
mahimapandey786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt.KHUSHILAL SHARMA GOVT. (AUTO.) AYURVEDA COLLEGE AND INSTITUTE, BHOPAL MP |
|
|
Primary Sponsor
|
| Name |
Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
| Address |
SCIENCE HILL BEHIND MANIT ,KOLAR NEHARU NAGAR BYPASS ROAD ,BHOPAL
BHOPAL
MADHYA PARADESH
462003
INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 MAHIMA PANDEY |
Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT ,ROOM NO. 6 ,SCIENCE HILL BEHIND MANIT ,KOLAR NEHARU NAGAR BYPASS ROAD ,BHOPAL
BHOPAL
MADHYA PARADESH
462003
INDIA
Bhopal
MADHYA PRADESH |
7879725791
mahimapandey786@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:M259||Joint disorder, unspecified. Ayurveda Condition: PATIENTS, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with sign and symptoms of Vatarakta.
2. Patients between the age group of 21 to 65 years, either sex and irrespective of
socioeconomic status.
3. Patients willing to sign consent form for the study. |
|
| ExclusionCriteria |
| Details |
1. Patient not fulfilling the inclusion criteria .
2. Patients having Paralysis and associated diseases like Cardiac disease, Malignancy,
Tuberculosis, Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Renal Function
impairment, Hypertension, RHD etc.
3. Pregnant women and Lactating mothers.
4. Patients having any type of arthropathy like, Ankylosing spondylosis, Rheumatoid
arthritis, Traumatic arthritis, Neoplasm of spine & Pyogenic osteomyelitis etc.
5. Patients not willing to sign the consent form for participating in research study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is relation between Lipid Profile & Elevated Uric Acid in Vatarakta (Gout). |
The estimated time of study is upto 48 weeks (May 2023). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is further expected that the relation of lipid profile and elevated uric acid in vatarakta will be helpful in the management of clinical practice of vatarakta(gout). |
12 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/05/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
CRITERIA FOR DIAGNOSIS : Patients having more than 03 signs and symptoms of Vatarakta e.g. ï¶ SandhiShool (Joint Pain) ï¶ SandhiShotha (Oedema of Joints) ï¶ Stabdhata (Stiffness) ï¶ Supti (Sparshagyan) ï¶ Daha (Inflammation) ï¶ Sphurana (Tingling Sensation) ï¶ Toda (Pricking Sensation) ï¶ Vaivarnya (Discoloration) ï¶ SparshaAsahatva (Tenderness)
CRITERIA FOR SELECTION OF PATIENTS:
INCLUSION CRITERIA : 1. Patients presenting with sign and symptoms of Vatarakta. 2. Patients between the age group of 21 to 65 years, either sex and irrespective of
socioeconomic status. 3. Patients willing to sign consent form for the study.
EXCLUSION CRITERIA : 1. Patient not fulfilling the inclusion criteria . 2. Patients having Paralysis and associated diseases like Cardiac disease, Malignancy,
Tuberculosis, Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Renal Function
impairment, Hypertension, RHD etc. 3. Pregnant women and Lactating mothers. 4. Patients having any type of arthropathy like, Ankylosing spondylosis, Rheumatoid
arthritis, Traumatic arthritis, Neoplasm of spine & Pyogenic osteomyelitis etc. 5. Patients not willing to sign the consent form for participating in research study.
LABORATORY INVESTIGATIONS: 1. Lipid Profile 2. Kidney Function Test (KFT) 3. Complete Blood Count (CBC) 4. Erythrocyte Sedimentation Rate (ESR) |