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CTRI Number  CTRI/2015/02/005559 [Registered on: 20/02/2015] 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 HARIJIVAN 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 SIDHARTHA SAMAL 
Designation  ASSISTANT PROF 
Affiliation  INSTITUTE OF MEDICAL SCIENCE AND SUM HOSPITAL  
Address  DEPARTMENT OF ORTHOPAEDICS AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
DEPARTMENT OF ORTHOPAEDICS AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
Khordha
ORISSA
751003
India 
Phone  8908225125  
Fax    
Email  sidhusamal46@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
Khordha
ORISSA
751003
India 
Phone  9439523875  
Fax    
Email  drjsahoo@gmail.com  
 
Source of Monetary or Material Support  
AYUSH ARIHANT INDUSTRIES 
 
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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sidhartha Samal  ORTHOPAEDIC OPD   INSTITUE OF MEDICAL SCIENCE AND SUM HOSPITAL AT K8 KALINGA NAGAR PO GHATIKIA BHUBANESWAR 751003 ODISHA INDIA
Khordha
ORISSA 		 08908225125

sidhusamal46@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  CHRONIC PAIN,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AYUSH HARIJIVAN 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  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 DISEASE 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   "NONE YET" 
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.

HARIJIVAN IS A POLYHERBAL AYURVEDIC FORMULATION CONTAINING KATU TAILA (Brassica campestris), NILGIRI TAILA (Eucalyptus globules), KARPOORA (Cinnamomum camphora), CARBO TAILA (Acidum carbonicom), LAHASUN (Allium sativa), JAIPHAL (Myristica fragrans) AND MARICH (Piper nigarm).  

ALL OF THESE INGREDIENTS HAVE ALREADY PROVED ITS EFFICACY IN THE MANAGEMENT OF PAIN IN AYURVEDIC SCIENCE.

THE PRESENT STUDY ENTITLED â€œTHERAPUTIC EVALUATION OF HARIJIVAN OIL FOR PAIN RELIEF”.

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. 

 
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