| CTRI Number |
CTRI/2022/07/043798 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
06/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of nirgundi and hadjod base formulation on knee joint ostioarthritis |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Nirgundi and Hadjod based oral and topical formulation on knee joints of osteoarthritic patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANIL KUMAR SHARMA |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
R G GOVT P G AYURVEDIC COLLEGE PAPROLA |
| Address |
R G GOVT P G AYURVEDIC COLLEGE PAPROLA DISTRICT KANGRA 176115 HIMACHAL PRADESH INDIA
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805056393 |
| Fax |
|
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANIL KUMAR SHARMA |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
R G GOVT P G AYURVEDIC COLLEGE PAPROLA |
| Address |
R G GOVT P G AYURVEDIC COLLEGE PAPROLA DISTRICT KANGRA 176115 HIMACHAL PRADESH INDIA
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805056393 |
| Fax |
|
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANIL KUMAR SHARMA |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
R G GOVT P G AYURVEDIC COLLEGE PAPROLA |
| Address |
R G GOVT P G AYURVEDIC COLLEGE PAPROLA DISTRICT KANGRA 176115 HIMACHAL PRADESH INDIA
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805056393 |
| Fax |
|
| Email |
dranilpaprola@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSIR IHBT PLAMPUR DISTRICT KANGRA HIMACHAL PRADESH INDIA 176061 |
|
|
Primary Sponsor
|
| Name |
CSIR NEW DELHI HCP |
| Address |
CSIR NEW DELHI ANSANDHAN BHAWAN 2 RAFI MARGBSANSAND MARG AREA |
| Type of Sponsor |
Research institution |
|
|
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 ANIL KUMAR SHARMA |
OPD NO 213 Surgery Department |
R G GOVT P G AYURVEDIC HOSPITAL PAPROLA
Kangra
HIMACHAL PRADESH |
9805056393
dranilpaprola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R G GOVT P G AYURVEDIC COLLEGE PAPROLA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GLUCOSAMINE PREPARATION |
GLUCOSAMINE AS A FOOD SUPPLIMENT 500 MG BD ORALLYFOR 6 WEEKS |
| Intervention |
NIRGUNDI AND HADJOD BASE ORAL AND TROPICAL FORMULATION |
NIRDUNGI AND HADJOD WATER DISPENSER POWER ORALLY 500 MG BD AND LOCAL APPLICATION OF TROPICAL FORMULATION TWICE A DAY FOR 6 WEEKS. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers with affected joints,who are willing to undergo the treatment.
Age between 40 -70 years.
Individuals who are willing and able to participate for 6 months of duration.
|
|
| ExclusionCriteria |
| Details |
Patients not willing for trial.
Patients below the age of 40 years and above 70 years.
Patients who have participated in any clinical trial during past 6 months.
Subjects with cardiac problems.
Subjects with uncontrolled diabetes mellitus
Subjects with multiple joint disorders.
Subjects with advanced rheumatoid arthritis.
Subject advanced knee osteoarthritis.
Subjects suffering from major systemic illness necessitating long term drug treatment (R.A, PTB, malignancy etc.)
Any other condition which the Investigator thinks may compromise the safety of the subject
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement will be evaluated by objective evaluation of knee joints (affected joint or both joints) (mandatory); X-ray and MRI depending upon availability. It will be done to check the efficacy of the productOSTEOARTHRITIS PATIENT.
EFFECT ON CHOLEGEN HEALTH |
8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other parameters such as Complete Blood Count, ESR, Liver function test, renal function test etc will be evaluated to check safety and any adverse effect on the patient. |
8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
14/07/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A CLINICAL STUDY TO EVALUTE THE EFFICACY OF NIRGUNDI AND HADJOD BASE ORAL AND TROPICAL FORMULATION ON KNEE JOINT OF OSTIOARTHRITIS PATIENTS WILL BE DONE ON 60 PATIENTS AS PER OUR INCLUSION AND EXCLUSION CRITERIA ON THE DURATION OF 6 MONTH. AFTER COMPLETION OF TRIAL THE OUTCOME WILL ANALYZED AS PER SUBJECTIVE AND OBJECTIVE PARAMETER.AFTER C.OMPLETION OF THE STUDY WE WILL PUBLISE THE STUDY ON REPUTATE JOURNAL. |