| CTRI Number |
CTRI/2020/07/026267 [Registered on: 01/07/2020] Trial Registered Retrospectively |
| Last Modified On: |
24/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Physiotherapy (Not Including YOGA)
Other (Specify) [Upanaha] |
| Study Design |
Other |
|
Public Title of Study
|
Management of Janusandhigata Vata (Knee Joint Osteoarthritis) With Upanaha and Physiotherapy (Ultrasound) |
|
Scientific Title of Study
|
A Randomized Controlled Study to Evaluate the Integrative Management of Janusandhigata Vata (Knee Joint Osteoarthritis) With Upanaha and Physiotherapy (Ultrasound) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun kumar Gupta |
| Designation |
P G Scholar |
| Affiliation |
Post Graduate Studies and Research Center K L E Us Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum |
| Address |
Post Graduate Studies and Research Center
K L E Us Shri BMK Ayurveda Mahavidyalaya
Shahapur Belgaum
Post Graduate Studies and Research Center
K L E Us Shri BMK Ayurveda Mahavidyalaya
Shahapur Belgaum
Belgaum
KARNATAKA
590003
India |
| Phone |
8792493376 |
| Fax |
8312424157 |
| Email |
arungupta.5983@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B S Prasad |
| Designation |
Principal & HOD Dept. of Panchakarma |
| Affiliation |
Post Graduate Studies and Research Center K L E Us Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum |
| Address |
Post Graduate Studies and Research Center
K L E Us Shri BMK Ayurveda Mahavidyalaya
Shahapur Belgaum
Post Graduate Studies and Research Center
K L E Us Shri BMK Ayurveda Mahavidyalaya
Shahapur Belgaum
Belgaum
KARNATAKA
590003
India |
| Phone |
9448569289 |
| Fax |
9448569289 |
| Email |
dr_bsprasad@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun kumar Gupta |
| Designation |
P G Scholar |
| Affiliation |
Post Graduate Studies and Research Center K L E Us Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum |
| Address |
Post Graduate Studies and Research Center
K L E Us Shri BMK Ayurveda Mahavidyalaya
Shahapur Belgaum
Post Graduate Studies and Research Center
K L E Us Shri BMK Ayurveda Mahavidyalaya
Shahapur Belgaum
Belgaum
KARNATAKA
590003
India |
| Phone |
8792493376 |
| Fax |
8312424157 |
| Email |
arungupta.5983@gmail.com |
|
|
Source of Monetary or Material Support
|
| shri BMK Ayurveda MahavidyalayaPost Graduate Studies and Research Center
Shahapur Belgaum Karnataka |
|
|
Primary Sponsor
|
| Name |
Shri BMK Ayurveda MahavidyalayaPost Graduate Studies and Research Center |
| Address |
Shahapur Belgaum Karnataka
|
| 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 Arun Kumar Gupta |
K L E U s Shri B M K Ayurveda Mahavidyalaya Post Graduate Studies and Research Center |
Department of Panchakarma,Sharaf Gali, House Number- A/48 Shahapur Belgaum
590003
Belgaum
KARNATAKA |
8989243480
7999767255
arungupta.5983@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ehtics Comittee for research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Janusandhigata vata (knee osteoarthritis), (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound |
Once in a day for 5 minute Total duration- 7 days |
| Intervention |
Upanaha |
Once in a day for 12 hour Total duration- 7 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with classical signs and symptoms of Janusandhigatvata like vatapurnadrithisparshansopham (swelling), prasaranaakunchanyovedanam (pain on extension andflexion movement) and sandhigraham (restricted range of movements) |
|
| ExclusionCriteria |
| Details |
1.Patients showing signs and symptoms of gout, rheumatoid arthritis.
2.Acute joint trauma.
3.Complete loss of articular cartilage.
4.Known case of skin allergy and open wound.
5.Pitta associated with signs and symptoms like: daha, raga and ushma
6.Samavata condition
7.Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Group A(15 Patients) treated with Upanaha may have relief up t0 60-70 percentage, Group B(15 patients) treated with Ultrasound may have relief 50-60 percentage and Group C (15 patients) Treated with combined therapy patient may have relief upto 70-80% percentage |
Results will outcome in 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| group A, Group B, Group C where patients may be reduction of pain ,Stiffness, Difficulties, reduction knee joint swelling, reduction of Tenderness and improved Range of motion by 50-80 %. |
total duration 7 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/05/2014 |
| Date of Study Completion (India) |
25/01/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Publihed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis has high prevalence, especially in the elderly, and the
high rate of disability related to disease makes it a leading cause of
disability in the elderly. In the United
States, osteoarthritis prevalence will increase from 66–100% by the year 2020 Sandhigatavata can be compared with Osteoarthritis of contemporary
medical science. Osteoarthritis is the second largest musculoskeletal disorder
in the world (30%) after low back pain (50%). The reported prevalence of
Osteoarthritis from a study in rural India is 5.78% The hip and knee are the principle large joints affected and are the
principle sites of significant disability. Knee osteoarthritis is more prevalent
than hip osteoarthritis, but taken together they affect 10-25 % of those aged
over 65years. Sandhigatavata is one of vatavyadhi explained in our
classics, in which swelling, painful movements of the joints are seen. It is treated “Snehana,swedan,upanaha,agnikarma,bandhana, mardan’’
,Raktamokshana, matrabasti nirgundi patrapindasweda,
which are
emphasized to provide better relief of pain
and swelling and to restore the mobility. Upanaha swedana is used in vatavyadhi which relives
shula (pain), sankoca(restricted movement), and stambha (stiffness) Ultra sonic therapy was introduced into the United States in 1949
after establishing its reputation as an efficient therapeutic modality in Europe.
A British study in 1954, based on a tabulation of 100,000 cases, reported
excellent results of its use in 60-70 percent of cases of arthritis. Ultrasound demonstrates the ability to evoke a
broad range of therapeutically beneficial effects which may provide safe and
effective applications in the management of osteoarthritis. Hence this study
attempts to determine the effect of two different forms of therapies that is upanaha
and ultrasound in Janusadhigatavata (osteoarthritis of knee joints).
|