| CTRI Number |
CTRI/2021/07/034925 [Registered on: 16/07/2021] Trial Registered Prospectively |
| Last Modified On: |
14/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Knee joint pain management through Ayurvedic Medicines |
|
Scientific Title of Study
|
“A prospective community based study for the evaluation of YograjGuggulu, Ashwagandha Churna and Narayana Taila in Osteoarthritis Knee (JanugatSandhivata)†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Prasad A J V |
| Designation |
Research Officer(Ayu) |
| Affiliation |
RARI Vijayawada CCRAS New Delhi |
| Address |
Regional Ayurveda Research Institute new Rajeev nagar payakapuram Vijayawada
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9490716761 |
| Fax |
|
| Email |
saiprasad_avvaru@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sai Prasad A J V |
| Designation |
Research Officer(Ayu) |
| Affiliation |
RARI Vijayawada CCRAS New Delhi |
| Address |
Regional Ayurveda Research Institute new Rajeev nagar payakapuram Vijayawada
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9490716761 |
| Fax |
|
| Email |
saiprasad_avvaru@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sai Prasad A J V |
| Designation |
Research Officer(Ayu) |
| Affiliation |
RARI Vijayawada CCRAS New Delhi |
| Address |
Regional Ayurveda Research Institute new Rajeev nagar payakapuram Vijayawada
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9490716761 |
| Fax |
|
| Email |
saiprasad_avvaru@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| CCRAS Under Ministry of AYUSH |
|
|
Primary Sponsor
|
| Name |
CCRAS New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No 61-65 Institutional Area Opp D Block Janakpuri
New Delhi 110058 ( India ) |
| Type of Sponsor |
Other [Central Government Under Ministry of AYUSH Government of INDIA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P L Bharathi |
CARI Guwahati |
Department of Ayurveda AMHCPSCSP division Room Number 212 Barsojai Beltola Guwahati
Kamrup
ASSAM |
9407587686
plbharati@rediffmail.com |
| Dr Sandeep R Baheti |
CARI Patiala |
Room number 107 Department of Ayurveda AMHCP under SCSp division motibagh Road patiala
Patiala
PUNJAB |
9422540609
sandiprbaheti@gmail.com |
| Dr Parth Dev |
RARI Ahmedabad |
Department of Technical Division of AMHCP SCSP Room Number 22 Asarwa Ahmedabad
Jamnagar
GUJARAT |
9638948973
drppdave88@gmail.com |
| DrRahul Dhanrajji Ghuse |
RARI Gangtok |
Department of Technical Section Division of AMHCPSCSP Room number 3 Tadong East Sikkim
East
SIKKIM |
9665927690
ghuserahul@gmail.com |
| Dr Deepa Sarma |
RARI Gwalior |
Department of Ayurveda Division of AMHCP SCSP Room number 36 Amkho Gwalior
Gwalior
MADHYA PRADESH |
9450109125
sha.dpa@gmail.com |
| Dr A K Srivatsava |
RARI lucknow |
Department of Ayurveda Division of AHMCP SCSP Room Number 104 INS 106 Sect-25 Indira nagar
Lucknow
UTTAR PRADESH |
9792913313
drakspatt@gmail.com |
| Dr Chris Antony |
RARI Mandi |
Department of Ayurveda Divisionof AHMCP SCSP Room Number 04 Jaralpande Mandi
Mandi
HIMACHAL PRADESH |
7807773464
chrisantony1@gmail.com |
| Dr UR Sekhar Namburi |
RARI Nagpur |
Department of Ayurveda Division of Technical Section Room Number 217 NIT Complex Nandanvan Nagpur
Gadchiroli
MAHARASHTRA |
8055595355
shilpasekhar2k5@yahoo.com |
| Dr Sai Prasad A J V |
RARI Viajayawada |
Department of Ayurveda SCSP AMHCP division Room number 204 New rajeev nagar payakapuram Vijayawada
Krishna
ANDHRA PRADESH |
9490716761
saiprasad_avvaru@yahoo.co.in |
| Dr Gopesh Kumar Sharma |
Regional Ayurveda Research Institute, Jammu |
Department of Ayurveda AMHCPSCSP Division Room Number 8 OPD Block Rajinder Nagar, Bantalab, Jammu-181123
Jammu
JAMMU & KASHMIR |
9015947900
drgopeshsharma@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee CARI Guwahati |
Approved |
| Institutional Ethics Committee CARI Patiala |
Approved |
| Institutional Ethics Committee RARI Lucknow |
Approved |
| Institutional Ethics Committee RARI Ahmadabad |
Approved |
| Institutional Ethics Committee RARI Gangtok |
Approved |
| Institutional Ethics Committee RARI Gwalior |
Approved |
| Institutional Ethics Committee RARI Jammu |
Approved |
| Institutional Ethics Committee RARI Mandi |
Approved |
| Institutional Ethics Committee RARI Nagpur |
Approved |
| Institutional Ethics Committee RARI Vijayawada |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yograj Guggulu , Reference: (AFI – Part I, 5 : 7), Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: Nil(2) Medicine Name: Ashwagandha Churna , Reference: (API – Part I, Vol.-I), Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: Nil(3) Medicine Name: Narayan Taila , Reference: (AFI–Part I, 8 : 23), Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Participant of any gender in the age group 40-65 yrs of Scheduled Caste community
2. Participant who are willing to provide written consent.
3. Participant of primary Osteoarthritis knee (Unilateral/ bilateral) as per any one of the following three ACR diagnostic criteria
1. Using history and physical examination
Pain in the Knee and 3 of the following:
i. Over 50 years of age.
ii. < 30 minutes of morning stiffness
iii. Crepitus on active motion
iv. Bony tenderness
v. Bony enlargement
vi. No palpable warmth
2. Using radiographic findings: (if available)
Pain in the Knee and 1 of the following:
i. Over 50 years of age.
ii. < 30 minutes of morning stiffness
iii. Crepitus on active motion and osteophytes.
3. Using history, physical examination and laboratory findings: (if available)
Pain in the Knee and 5 of the following:
i. Over 50 years of age.
ii. < 30 minutes of morning stiffness
iii. Crepitus on active motion
iv. Bony tenderness
v. Bony enlargement
vi. No palpable warmth of synovium
vii. ESR < 40mm/hour
viii. Rheumatoid Factor (RF) < 1:40
ix. Synovial fluid (SF) signs of osteoarthritis
|
|
| ExclusionCriteria |
| Details |
i. Diagnosed cases of Rheumatoid arthritis or other type of inflammatory arthritis or patients who report to have been under anti-arthritic medication for RA or inflammatory arthritis.
ii. Participant prescribed Joint replacement surgery.
iii. Participant with history of trauma to the afflicted joint.
iv. Use of ambulatory aids such as wheel chair, walker etc
v. Someone who has BMI≥32kg/m² at the screening visit.
vi. Co-morbid conditions such as past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
vii. Known case of Renal/ Hepatic / Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease, Uncontrolled DM or HTN.
viii. Pregnant women/ women who are planning for conception and lactating women
ix. Patient taking participation in any other clinical trial.
x. Any other condition which the P.I. thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i. Changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total score [Time frame: from base line to end of 4th, 8th, 12th week, 16th week] Indian WOMAC (Modified –CRD Pune Version) |
i. Changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total score [Time frame: from base line to end of 4th, 8th, 12th week, 16th week] Indian WOMAC (Modified –CRD Pune Version) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Change in the Visual Analogue Scale (VAS) for pain
ii. Assessment of changes in Ayurvedic disease specific symptoms of sandhivata
iii. Frequency of use of no. of NSAID / analgesic medication
iv. Change in WOMAC Pain, stiffness, physical activity score
i. Tolerability assessed by proportion of recruited participants remaining in the trial intervention, during the trial.
|
baseline, 4th, 8th, 12th week and end of the 16th week |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/07/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/07/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
paper will published after completion of the project |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study title:A prospective community based study for the evaluation of Yograj Guggulu, Ashwagandha Churna and Narayan Taila in Osteoarthritis Knee (JanugatSandhivata) This is a research study being conducted under the Ayurveda Mobile Health Care Programme (AMHCP) by Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous organization under Ministry of AYUSH, Government of India, involving administration of Yograj Guggulu, Ashwagandha Churna and Narayan Taila with an objective to assess the role of the intervention in Osteoarthritis Knee (JanugatSandhivata). |