| CTRI Number |
CTRI/2017/11/010410 [Registered on: 07/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
23/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study of Treatment of Cervical Spondylosis by Ayurvedic drug |
|
Scientific Title of Study
|
Clinical Evaluation of Panchamrit Lauha Guggulu and Panchguna Taila in the management of Cervical Spondylosis(Greeva Graha) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S K Sharma |
| Designation |
Assistant Director (Ayu.) Incharge |
| Affiliation |
Regional Ayurveda Research Institute for Nutritional Disorders |
| Address |
Regional Ayurveda Research Institute for Nutritional Disorders,
Gandhi Bhawan,
Mandi (HP)
Mandi
HIMACHAL PRADESH
175001
India |
| Phone |
9418062731 |
| Fax |
01905222857 |
| Email |
dr.sk.sharma.ad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Sharma |
| Designation |
Assistant Director (Ayu.) Incharge |
| Affiliation |
Regional Ayurveda Research Institute for Nutritional Disorders |
| Address |
Regional Ayurveda Research Institute for Nutritional Disorders,
Gandhi Bhawan,
Mandi (HP)
Mandi
HIMACHAL PRADESH
175001
India |
| Phone |
9418062731 |
| Fax |
01905222857 |
| Email |
dr.sk.sharma.ad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S K Sharma |
| Designation |
Assistant Director (Ayu.) Incharge |
| Affiliation |
Ayurveda Regional Research Institute for Nutritional Disorders |
| Address |
Regional Ayurveda Research Institute for Nutritional Disorders,
Gandhi Bhawan,
Mandi (HP)
Mandi
HIMACHAL PRADESH
175001
India |
| Phone |
9418062731 |
| Fax |
01905222857 |
| Email |
dr.sk.sharma.ad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council For Research In Ayurvedic Sciences, (CCRAS) Ministry AYUSH,
Jawahar Lal Nehru Bhartiya Chikitsa evam Homeopathy Anusandhan Bhawan No. 61-65, Institutional Area opp. D Block, Janakpuri, New Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
Ceneral Council For Research In Ayurvedic SciencesCCRAS |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61-65,Institutional Area, Opposite 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 Om Raj Sharma |
Regional Ayurveda Research Institute For Nutritional Disorders |
Gandhi Bhawan, Mandi (HP)-175001
Mandi
HIMACHAL PRADESH |
9418062731
01905222857
arri.mandi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Ayurveda Research Institute For Nutritional Disorders Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients Suffering From Cervical Spondylosis (Greevagraha), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clinical Evaluation of Panchamrit Lauha Guggulu and Panchguna Taila in the management of Cervical Spondylosis(Greeva Graha) |
1. Panchamrit Lauha Guggulu (The Ayurvedic Formulary of India Part-II, 5 : 1)
Dose : 2 tablets twice daily. (125mgx2xbd)
Dosage form : Tablet of 125mg each
Route of Administration : Oral.
Time of Administration : Twice a day after food.
Anupana : Lukewarm Water.
Duration of therapy : 12 weeks.
2. Panchaguna Taila (The Ayurvedic Formulary of India Part-II ,8:7)
Dose : 10 ml, Local Application.
Dosage form : Oil.
Route of Administration : Local Application.
Time of Administration : Twice a day
Duration of therapy : 12 weeks.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex with age between 30 and 60 years.
2.MRI Neck, findings suggestive of degenerative changes & cervical spondylosis.
3.Patients with or without radiculopathy.
4.Intermittent neck and shoulder pain.
5.Restricted movement of neck.
|
|
| ExclusionCriteria |
| Details |
1.Age below 30 years and above 60 years
2.Patients with cervical myelopathy.
3.Patients with neck pain and other degenerative signs due to other reasons like spondylolysthesis, cervical spinal stenosis, diseases of atlanto-occipital joint, meningitis, atlantoaxial joint, muscle strain or soft tissue etiology, pregnancy, tumours, internal bleeding(haematoma)infection, injury, Pott’s disease etc.
4.Patients with congenital cervical rib and acquired Spinal deformity(Pott’s fracture, compression fracture etc)
5.Patients with poorly controlled Hypertension ( >160/100 mmHg)
6. Patients with uncontrolled Diabetes Mellitus having Hb A1C of > 8%
7.Patients on medication with corticosteroids, phototherapy, biologics, antidepressants any other drugs that may have an influence on the outcome of the study.
8.Known cases of cardiovascular diseases, hepatic disorders, Renal Disorders, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Malignancy or any other condition that may jeopardize the study.
9. Alcoholics and/or drug abusers/ chain smokers.
10.Chronic Rheumatological and auto-immune diseases like RA, Psoriatic arthropathy, Gout, SLE.
11. H/o hypersensitivity to any of the trial drugs or their ingredients.
12.Patients who have completed participation in any other clinical trial during the past six months
13.Any other condition which the Investigator 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 |
| Relief in Signs & Symptoms (pain and associated complaints) of the disease by reduction in the Northwick Park Neck Pain questionnaire |
Relief in Signs & Symptoms (pain and associated complaints) of the disease by reduction in the Northwick Park Neck Pain questionnaire after every 14 Days upto at the end of 98th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in health status by SF 36 Questionnaire(Rand-36) |
Basline and at the end of 12 weeks and follow up at the end of 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/03/2017 |
| Date of Study Completion (India) |
22/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/11/2019 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is an IMR Project under CCRAS Ministry of Ayush, New Delhi. This is
single group open label prospective interventional uni-centric (RARIND
MANDI,H.P. INDIA) study to evaluate the efficacy of PANCHAMRIT LAUHA GUGGULU
and PANCHGUNA TAILA in the Management of GREEVA GRAHA (CERVICAL SPONDYLOSIS).
The primary outcome measures will be relief in signs and symptoms (pain and
associated complaints) of the disease by reduction in the Northwick Park Neck
Pain questionnaire after every 14 days upto at the end of 98th day.
The secondary outcome measures will be improvement in health status by SF36
Questionnaire (RAND 36) at the baseline, at the end of 12 weeks and at the end of
follow up (2 weeks). |