| CTRI Number |
CTRI/2017/09/009907 [Registered on: 25/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic treatment for pain |
|
Scientific Title of Study
|
Evaluation of analgesic and anti-infammatory activities of CONTRAPAIN -LEPA& OIL topical application in Musculoskeletal Disorders - CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPradeep L Grampurohit |
| Designation |
Reader |
| Affiliation |
KLEUs Shri BMK Ayurveda Mahavidyalaya, Belagavi |
| Address |
Reader, Department of Panchakarma
KLEUs Shri BMK Ayurveda Mahavidyalaya, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9964144197 |
| Fax |
08312424157 |
| Email |
pradeepgrampurohit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPradeep L Grampurohit |
| Designation |
Reader |
| Affiliation |
KLEUs Shri BMK Ayurveda Mahavidyalaya, Belagavi |
| Address |
Reader, Department of Panchakarma
KLEUs Shri BMK Ayurveda Mahavidyalaya, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9964144197 |
| Fax |
08312424157 |
| Email |
pradeepgrampurohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPradeep L Grampurohit |
| Designation |
Reader |
| Affiliation |
KLEUs Shri BMK Ayurveda Mahavidyalaya, Belagavi |
| Address |
Reader, Department of Panchakarma
KLEUs Shri BMK Ayurveda Mahavidyalaya, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9964144197 |
| Fax |
08312424157 |
| Email |
pradeepgrampurohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| MB Life Sciences Pvt.Ltd
54/8, Desh Bandhu,
Gupta Road, Karol Bagh,
New Delhi, India |
|
|
Primary Sponsor
|
| Name |
MB Life Scienes Pvt Ltd New Delhi |
| Address |
54/8, Desh Bandhu,
Gupta Road, Karol Bagh,
New Delhi, India |
| 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 |
| DrPradeep L Gramapurohit |
KLEUs Shri BMK Ayurveda Mahavidyalaya, Belagavi |
Room number4, Panchakarma Department
Belgaum
KARNATAKA |
9964144197
08312424157
pradeepgrampurohit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ïµ Eighty (80) patients with MSD, meeting all inclusion/exclusion criteria will be included in the study, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Contrapain Lepa and Oil |
Lepa powder contains drugs like Sigru, Punarnava, Kunduru, Rasna, Daruharidra, Shunthi, Lodhra, Devadaru,Nausadara, Chitraka, Sphatika
Oil contains NirgundiPatra (Lf.), Erandamool - (Rt.), Rasna - (Lf.), Mahabala (Rt.), TilaTaila – (Seed Oil), Karpura, Menthol, Thymol ( Oil ), Tailaparna Taila- (Oil ), Gandhapura Taila - (Oil), Kattrina- (Wh.Plant), Katuveera–
( Fruit), Light Liquid Paraffin, Dalchini Taila
(Oil ), Lavanga Taila – (Oil)
5grams of contrapain lepa powder mixed with lukewarm water applied at the site of pain for the duration of 30-60 minutes and this will be followed by application of contrapain oil twice daily for seven days. Post-treatment follow-up is 15th and 30th Day |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with musculoskeletal pain and swelling, fulfilling the diagnostic criteria of MS, willing to give consent for participating in the study. Patients who are currently on analgesics/NSAID, will be given a washout period of 7days prior to recruitment |
|
| ExclusionCriteria |
| Details |
Patients having severe MSD, those who are suffering from dermatitis or had a history of dermatitis, pregnant and lactating women, any other conditions which in the opinion of investigator will places the subject at risk or will influence the conduct of study or interpretation of results |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Before and after the treatment period of 7 days
Changes in following parameters between day 1 and day 7:
• Subjective parameters: Pain (VAS), Tenderness, Shotha (swelling/Inflammation), Stabdata (Stiffness), Physician Global Assessment
• Objective parameters: Range of Motion (Goniometer)
At screening: RA, CRP, Serum Uric acid
Safety Parameters: CBC, LFT, RFT (base line and 7th day) (Only 50% of Patients)
|
Day 0, 8, 22,37 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of subsidence after treatment period during the follow-up period up to 30 days.
Subjective parameters will be assessed on day 15th and 30th day
|
Day0, 8, 22 and 37 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/05/2017 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Yet to Publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Topical application of paste prepared by mixing 5gm of Contrapain (Lepa) powder in lukewarm water for application at the site of pain for the duration of 30 to 60 minutes. Lepa will be removed with help of running water and allow it to dry. This will be followed by application of Contrapain oil |