| CTRI Number |
CTRI/2020/07/026737 [Registered on: 22/07/2020] Trial Registered Prospectively |
| Last Modified On: |
16/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Ayurvedic and Allopathic Treatment in the patients of Knee Osteoarthritis |
|
Scientific Title of Study
|
A comparative clinical study of effectiveness of Ayurvedic and Conventional management in the patients of Sandhigata Vata of Janu (Knee osteoarthritis) with special reference to quality of life |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi Kathait |
| Designation |
PhD scholar |
| Affiliation |
Intitute of Medical Science Banaras Hindu University |
| Address |
Department of Kayachikitsa,Faculty of Ayurveda, Institute of Medical
Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
sir sunderlal hospital
IMS BHU
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drrashmikathait@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Kathait |
| Designation |
PhD scholar |
| Affiliation |
Intitute of Medical Science Banaras Hindu University |
| Address |
Department of Kayachikitsa,Faculty of Ayurveda, Institute of Medical
Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
C/O Ashok Kumar Pandey
N8/180F-28
Kailash Vihar Colony
Sunderpur
Varanasi
UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drrashmikathait@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajai kumar pandey |
| Designation |
Assistant Professor |
| Affiliation |
Intitute of Medical Science Banaras Hindu University |
| Address |
Department of Kayachikitsa,Faculty of Ayurveda, Institute of Medical
Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
Department of Kayachikitsa
Faculty of Ayurveda
IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452827885 |
| Fax |
|
| Email |
drajaipandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| central council for research in ayurvedica sciences (CCRAS) New Delhi |
|
|
Primary Sponsor
|
| Name |
central council for research in ayurvedica sciences |
| Address |
Room No.206
2nd Floor JLNBCHA Bhawan
61-65 Institutional Area
Opp. D Block
Janakpuri
New Delhi-110058 |
| 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 Rashmi kathait |
sir sundarlal hospital, institute of medical science, BHU, Varanasi |
OPD/IPD of
Department of
Kayachikitsa,Indian
medicine wing, Institute
of Medical Sciences,
Banaras Hindu
University
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
7310643448
drrashmikathait@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
naproxen 500mg
naproxen gel 5% |
tablet naproxen twice a day along with naproxen gel local application two times a day 9 weeks |
| Intervention |
Trayodashang guggulu 500mg
Sahacharadi taila |
Trayodashang guggulu tablet two tablets twice a day with lukewarm water along with local application of sahacharadi taila twice a day for for 9 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling the Revised ACR 2016 criteria of Knee OA
2.Patients presenting with classical signs & symptoms of Osteoarthritis Knee
3.Patients’ age group between 50 years to 70 years irrespective of sex, religion, occupation and socioeconomic status.
4.Pain severity scale on VAS between 1 to 6 (i.e. mild to moderate)
5.Patients with BMD range of > -1.0 to -3.0
6.Patient with BMI >18.5 to<29.9
7.Patients who are willing to this trial. |
|
| ExclusionCriteria |
| Details |
1.Patients not fulfilling the Revised ACR 2016 criteria of Knee OA
2.Patients not fulfilling the classical sign and symptoms of OA.
3.Patient’s age group < 50 and > 70 years.
4.Patients with BMD range of < -3.0
5.Patient with BMI <18.5 to >29.9 (WHO)
6.Pain severity scale on VAS<1 and >6.
7.Patients having systemic disorder (Diabetic mellitus, Hypertension and other illness ) which might interfere with the treatment.
8.Patient of Autoimmune disorders, metabolic joint disorders or other than OA.
9.Patients with infective Neoplastic and traumatic condition of Knee joint. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any change in western Ontario and McMaster University osteoarthritis (WOMAC) score from baseline to the end of 3rd, 6th and 9th weeks of follow ups |
63days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of changes in (clinical symptoms) subjective parameters and objective parameters from baseline to the end of 3rd, 6th and 9th weeks.
Assessment of quality of life by using World Health Organization Quality of life (WHOQOL) BREF questionnaire. |
63days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
17/08/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
osteoarthritis one of the leading causes of disability worldwide.Undoubtedly modern medicine provides symptoms (pain
and swelling) related relief to the patient of osteoarthritis. However, dose
related toxicity & idiosyncrasy are the major obstacles for its long term
management. Effective management needs drug and measures to
minimize pain along with repair and strengthen bone and cartilage. Age
old holistic Ayurvedic approach management not only break the pathogenesis of
disease but also strengthen and enhance the body’s own healing process by
imparting appropriate nutritional support and strengthening the immune system.
In this concern by scanning large numbers of publication and reports Trayodashang
Guggulu of Bhaishajya Ratnavali (26/98-101) as oral medication and Sahacharadi Taila of Ashtanga Hridaya Chikitsa sthana (21/66-68) as local medications will be selected as Ayurvedic
management in the cases of Sandhigatavata
of Janu (osteoarthritis) and
categorized them as Ayurveda treated group. Besides, the study is
also comparing the effectiveness of an Ayurvedic intervention with
parallel conventional standard intervention in patient with knee
osteoarthritis. |