| CTRI Number |
CTRI/2015/02/005523 [Registered on: 10/02/2015] Trial Registered Retrospectively |
| Last Modified On: |
09/02/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EVALUATION OF A HERBAL MASSAGE OIL IN PAIN MANAGEMENT |
|
Scientific Title of Study
|
THERAPUTIC EVALUATION OF TULSHI JIWAN PLUS OIL FOR PAIN RELIEF |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KUNAL SHARMA |
| Designation |
TUTOR AND RESIDENT |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE AND SUM HOSPITAL |
| Address |
DEPARTMENT OF PHARMACOLOGY
AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
Khordha
ORISSA
751003
India |
| Phone |
8763155551 |
| Fax |
|
| Email |
doctorkunalsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAGANNATH SAHOO |
| Designation |
PROF AND HOD |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE AND SUM HOSPITAL |
| Address |
DEPARTMENT OF ORTHOPAEDICS
AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
PLOT NO 638 AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
Khordha
ORISSA
751003
India |
| Phone |
9439523875 |
| Fax |
|
| Email |
drjsahoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JAGANNATH SAHOO |
| Designation |
PROF AND HOD |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE AND SUM HOSPITAL |
| Address |
DEPARTMENT OF ORTHOPAEDICS
AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
PLOT NO 638 AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
Kendrapara
ORISSA
751003
India |
| Phone |
9439523875 |
| Fax |
|
| Email |
drjsahoo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AYUSH ARIHANT INDUSTRIES |
| Address |
NEAR KAPOOR BUILDING CINEMAPARA SUBASH CHOWK RAJGANGPUR SUNDERGARH 770017 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 KUNAL SHARMA |
ORTHOPAEDIC OPD |
INSTITUE OF MEDICAL SCIENCE AND SUM HOSPITAL AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
Khordha
ORISSA |
8763155551
doctorkunalsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE IMS AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
chronic pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AYUSH TULSHI JIWAN PLUS OIL |
LOCALLY - DOSE – 2-3 ML TWICE DAILY; DOSAGE FORM – OIL; ROUTE OF ADMINISTRATION – LOCAL APPLICATION; TIME OF ADMINISTRATION-TWICE A DAY; PACKING FORM- 25 ML PLASTIC BOTTLE; DURATION OF THERAPY-6 WEEKS |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
EITHER SEX AGED BETWEEN 30 TO 65 YEARS
PATIENTS WITH PRIMARY BACK, KNEE AND ANY MUSCULAR PAIN
WILLING AND ABLE TO PARTICIPATE IN THE STUDY |
|
| ExclusionCriteria |
| Details |
1. HISTORY OF ANY TRAUMA/ FRACTURED JOINT / SURGICAL/DIAGNOSTIC INTERVENTION WITH REFERENCE TO THE AFFECTED JOINT(S).
2. GROSS DISABILITY IN PERFORMING DAILY NORMAL ROUTINE I.E. BED RIDDEN PATIENTS OR CONFINED TO A WHEELCHAIR.
3. PATIENTS WITH CO MORBIDITIES SUCH AS GOUTY ARTHRITIS, RHEUMATOID ARTHRITIS AND PSORIATIC ARTHRITIS.
4. PATIENTS HAVING ANY DEFORMITY OF KNEE HIP OR BACK ALTERING THE GAIT AND POSTURE OF THE PATIENT.
5. PATIENTS WITH UNCONTROLLED HYPERTENSION (>160/100 MM OF HG).
6. PATIENTS WITH UNCONTROLLED DIABETES MELLITUS{HBA1C>9%}
7. PATIENTS WITH EVIDENCE OF MALIGNANCY.
8. PATIENTS ON PROLONGED (> 6 WEEKS) MEDICATION WITH CORTICOSTEROIDS, ANTIDEPRESSANTS, ANTICHOLINERGICS, ETC. OR ANY OTHER DRUGS THAT MAY HAVE AN INFLUENCE ON THE OUTCOME OF THE STUDY.
9. PATIENTS WHO HAVE A PAST HISTORY OF ATRIAL FIBRILLATION, ACUTE CORONARY SYNDROME, MYOCARDIAL INFARCTION, STROKE OR SEVERE ARRHYTHMIA IN THE LAST 6 MONTHS.
10. PATIENTS WITH ANY SEVERE RENAL OR HEPATIC OR ANY OTHER DISORDER WHICH MAY INTERFERE IN THE STUDY.
11. PREGNANT / LACTATING WOMAN.
12. PATIENTS WHO ARE CURRENTLY PARTICIPATING IN ANY OTHER CLINICAL TRIAL.
13. ANY OTHER CONDITION WHICH THE PRINCIPAL INVESTIGATOR THINKS MAY JEOPARDIZE THE STUDY.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CHANGE IN PATIENT’S GLOBAL ASSESSMENT OF THE CHRONIC PAIN ACTIVITY SCALE |
AT BASELINE, 7TH DAY, 14TH DAY, 21ST DAY, 28TH DAY AND AT THE END OF FOLLOW UP AFTER 06 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SAFETY AND EFFICACY OF THE DRUG IN THE PATIENT WITH CHRONIC PAIN |
AT BASELINE, 7TH DAY, 14TH DAY, 21ST DAY, 28TH DAY AND AT THE END OF FOLLOW UP AFTER 06 WEEKS |
|
|
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)
|
19/01/2015 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
TO BE PUBLISHED AFTER THE COMPLETION OF THE CLINICAL TRIALS. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THE INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL IS THE MEDICAL SCHOOL OF THE SIKSHA O ANUSANDHAN UNIVERSITY SITUATED IN BHUBANESWAR, ODISHA, INDIA. AIMED- 1. TO ASSESS THE SYNERGESTIC EFFECT OF ALL THESE COMBINED INGREDIENTS. 2. TO GENERATING EVIDENCE FOR THE SCIENTIFIC VALIDATION OF THE CLINICAL EFFICACY AND SAFETY OF THESE HERBAL FORMULATION. TULSHI JIVAN PLUS IS A POLYHERBAL AYURVEDIC FORMULATION CONTAINING MUSTARD OIL (Brassicaceae juncea), TARPIN OIL (Pinus bhutanica), LAHASUMN (Allium sativam), RATAN JOT (Onosma echioides), PUDINA SATWA (Mentha sylrestris), AJWAN SATWA (Trachyspermum ammi) AND KAPOOR (Camphora officinoroum). ALL OF THESE INGREDIENTS HAVE ALREADY PROVED ITS EFFICACY IN THE MANAGEMENT OF PAIN IN AYURVEDIC SCIENCE. THE PRESENT STUDY ENTITLED “THERAPUTIC EVALUATION OF TULSHI JIWAN PLUS OIL FOR PAIN RELIEFâ€. THIS INITIATIVE IS BASICALLY A SUPPLEMENT TO THE SIMILAR VENTURE BEING WORKED OUT AS AN ACTIVITY UNDER THE AYURVEDA CLINICAL TRIALS (A.C.T.) PROJECT OF THE AYURVEDIC PHARMACOPOEIA COMMITTEE (APC). THIS PROGRAMME IS EXPECTED TO SCIENTIFICALLY SUBSTANTIATE THE CLAIMS REGARDING CLINICAL EFFICACY AND SAFETY OF THESE CLASSICAL AYURVEDIC FORMULATIONS. |