| CTRI Number |
CTRI/2019/11/021883 [Registered on: 05/11/2019] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study on Ayuartis Capsule in arthritis of Neck |
|
Scientific Title of Study
|
A Randomized, Double blind, Placebo controlled, Comparative, Interventional, Multi-centric, Prospective, Clinical study to Evaluate Efficacy and Safety of Ayuartis Capsule in Patients Suffering From Cervical Spondylitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AYARTS/CS/WLX/2019, Version 1.0, 06th Aug 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Professor |
| Affiliation |
Khemdas Ayurved Hospital |
| Address |
Department of Kayachikitsa, Ground Floor, OPD No. 8, Khemdas Ayurved Hospital, P.O. Ishwarpura, Tal-Waghodia Dist.Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9096082950 |
| Fax |
|
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing, 402 A B C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing, 402 A B C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Welex laboratories Pvt. Ltd, 1002, Marathon Innova Nextgen, Off Ganpatrao
Kadam Marg, Lower Parel, Mumbai -13 |
|
|
Primary Sponsor
|
| Name |
Welex Laboratories Pvt Ltd |
| Address |
1002, Marathon Innova Nextgen, Off Ganpatrao
Kadam Marg, Lower Parel, Mumbai -13
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shishr Pande |
Ayurved Seva Sangh’s Ayurved Mahavidyalaya |
Department of Ayurved Sanshodhan Vibhag
OPD No 7A, Ground Floor, Ayurved Seva Sangh’s Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik, Maharashtra 422003
Nashik
MAHARASHTRA |
9420830818
shishir.nsk@gmail.com |
| Dr Vaishali Deshpande |
Khemdas Ayurved Hospital |
Department of Kayachikitsa, Ground Floor, OPD No. 8, Khemdas Ayurved Hospital, P.O. Ishwarpura, Tal-Waghodia, Dist.- Vadodra
Vadodara
GUJARAT |
9096082950
dr.vaishalid@gmail.com |
| Dr Narendrakumar Mundhe |
KVTR Ayurvedic College |
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR Ayurvedic College Boradi, Tal Shirpur Dist Dhule- 425428
Dhule
MAHARASHTRA |
9850378206
drnbmundhe@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PIAR-IECHR |
Approved |
| Institutional Ethics Committee, Ayurved seva sangh Ayurved Mahavidyalaya, Nashik |
Approved |
| Institutional Ethics Committee, KVTR Ayurvedic College, Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M509||Cervical disc disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayuartis Capsule |
contains Guggul Extract, Sallaki Extract, Motha, Prasarini Extract, Nirgundi Extract, Kutaj, Chopchini, Punarnava, Gokhru, Ajmoda, Bala, Ajwain, Methi Extract.
Dosage and Treatment Duration: 2 Ayuartis Capsules twice daily orally after meal with water for 90 days. |
| Comparator Agent |
Placebo Capsule |
contains starch and MCC having same size, colour and appearance, as that of investigational product. Dosage and Treatment Duration: 2 Placebo Capsules twice daily orally after meal with water for 90 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects having Neck Pain with or without radicular symptoms (paraesthe¬sia) since more than 2 months
2.Cervical spondylitis confirmed by radiological assessment (x-ray cervical vertebrae AP and Lateral view)
3.Subjects who are willing to give informed consent and ready to comply with the protocol.
4.Subjects who are ready to provide regular follow ups till the completion of the Study
|
|
| ExclusionCriteria |
| Details |
1.Known cases of trauma of neck, wry neck, vertebro basilar insufficiency, local wound and infection over neck, cervical rib syndrome, any spinal cord disorders other than cervical spondylitis, myelopathy and carpal tunnel syndrome
2.Known cases of shoulder and elbow musculoskeletal problems, fracture of spine and upper Limb
3.Known cases of Rheumatoid arthritis
4.Severe Osteoporosis as reported in cervical X Ray
5.Signs of nerve root compression of C1-C8, such as severe paresis, muscle loss, hyporeflexia,
6.Subjects with current use of steroidal medication prescribed for radiculopathy symptoms.
7.Subjects who use any other investigational drug within 1 month prior to randomization;
8.Known cases of tuberculosis, HIV, Ischemic Heart Disease, Cancer, uncontrolled hypertension, uncontrolled diabetes mellitus,
9.Pregnancy & Lactation.
10.Known hypersensitivity to ingredients used in study drug
11.Subjects with significant abnormal laboratory parameters
12.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in neck disability index (NDI) from baseline to end of study visit (comparison between the groups) |
Day -3, Day 0, Day 30, Day 60, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in neck pain using VAS
2. Change in tenderness, difficulty in neck movement, vertigo, imbalance, nausea, limited ROM in shoulder joints and paraesthesia in upper extremities using likert scale
3. Assessment of use of rescue medication
4. Global assessment for overall change by the subject and investigator
5. Tolerability of study drugs by assessing adverse events, laboratory parameters, and ECG.
|
Day -3, Day 0, Day 30, Day 60, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/11/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a randomized, double blind, placebo
controlled, comparative, interventional, multi-centric, prospective, clinical
study to evaluate efficacy and safety of Ayuartis Capsule in patients suffering
from cervical spondylitis. The study will be conducted at three sites in India.
As per computer generated randomization list, subject will be either randomized
to drug group or placebo group in 1:1 ratio. Subjects will be advised to take
given medication in a dose of 2 capsules twice daily orally after meals with
water for 90 days. The primary objective of the study will be to assess change
in neck disability index (NDI) from baseline to end of study visit (comparison
between the groups). The secondary objectives will be to assess change in neck
pain using visual analogue scale (VAS) from baseline to end of study visit
(comparison between the groups), change in tenderness, difficulty in neck
movement, vertigo, imbalance, nausea, limited ROM in shoulder joints and
paraesthesia in upper extremities using likert scale from baseline to end of
study visit (Comparison between the groups), use of rescue medication from
baseline to end of study visit (comparison between the groups), global
assessment for overall change by the subject and investigator at the end of
study treatment and tolerability of study drugs by assessing adverse events/ adverse
drug reactions, laboratory parameters, and ECG on study completion. |