| CTRI Number |
CTRI/2015/10/006300 [Registered on: 23/10/2015] Trial Registered Prospectively |
| Last Modified On: |
09/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Panchakarma Procedure] |
| Study Design |
Other |
|
Public Title of Study
|
An Ayurvedic Panchakarma therapy for cervical spondylosis. |
|
Scientific Title of Study
|
EVALUATION OF THE EFFECT OF JAMBEERA PINDA SWEDA IN CERVICAL SPONDYLOSIS WRT CLINICAL SYMPTOMATOLOGY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Sharma |
| Designation |
Research Officer (Ay.) |
| Affiliation |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES |
| Address |
Ayurvedic Central Research Institute,
Punjabi Bagh,
New Delhi
Central Council for Research in Ayurvedic Sciences,
Jawaharlal Nehru BhartiyaChikisaEvam Homoeopathy AnusandhanBhawan
61-65, Institutional Area, Opposite D-Block Janakpuri, New Delhi - 110058
West
DELHI
110026
India |
| Phone |
9013092250 |
| Fax |
01125225546 |
| Email |
drsakshi.sharma87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakshi Sharma |
| Designation |
Research Officer (Ay.) |
| Affiliation |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES |
| Address |
Ayurvedic Central Research Institute,
Punjabi Bagh,
New Delhi
Central Council for Research in Ayurvedic Sciences,
Jawaharlal Nehru BhartiyaChikisaEvam Homoeopathy AnusandhanBhawan
61-65, Institutional Area, Opposite D-Block Janakpuri, New Delhi - 110058
West
DELHI
110026
India |
| Phone |
9013092250 |
| Fax |
01125225546 |
| Email |
drsakshi.sharma87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Sharma |
| Designation |
Research Officer (Ay.) |
| Affiliation |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES |
| Address |
Ayurvedic Central Research Institute,
Punjabi Bagh,
New Delhi
Central Council for Research in Ayurvedic Sciences,
Jawaharlal Nehru BhartiyaChikisaEvam Homoeopathy AnusandhanBhawan
61-65, Institutional Area, Opposite D-Block Janakpuri, New Delhi - 110058
West
DELHI
110026
India |
| Phone |
9013092250 |
| Fax |
01125225546 |
| Email |
drsakshi.sharma87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences |
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
Central Council for Research in Ayurvedic Sciences,
Jawaharlal Nehru BhartiyaChikisaEvam Homoeopathy AnusandhanBhawan
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sakshi Sharma |
AyurvedaCentral Research Institute |
ACRI,
Road no. 66 Punjabi Bagh West, New Delhi-110026
West
DELHI |
9013092250
01125225546
drsakshi.sharma87@gmail.com |
| Dr P Radhakrishnan |
National Research Institute for Panchakarma |
National Research Institute for Panchakarma,
Cheruthuruthy P.O,Thrissur, Kerala
Thrissur
KERALA |
9495076710
04884-262366
dr.radhakrishnancrip@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACRI Institutional ethics Committee |
Approved |
| NRIPC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Cervical Spondylosis with clinical and radiological evidence of Cervical Spondylosis with or without cervical radiculopathy., (1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
JAMBEERA PINDA SWEDA |
The Jambeerapindasweda refers to the sudation performed by specially prepared bundles of Jambeera (citrus acida) fruit pieces. The procedure will be done for 14 days. The sudation will be done for 30-35 min. every day once in the morning. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Cervical Spondylosis with clinical and radiological evidence of Cervical Spondylosis with or without cervical radiculopathy.
2.Willing Patients with informed consent obtained.
|
|
| ExclusionCriteria |
| Details |
1. Age below 30 years and above 65 years.
2. Cases of cervical Spondylosis with intractable pain, neurological deficit, severe deltoid or wrist extensors weakness.
3. Patients with any cervical pathology apart from Cervical Spondylosis excluding any clinical evidence of Cervical Spondylotic myelopathy.
4. Patients with poorly controlled Hypertension ( 140/90 mmHg).
5. Patients with poorly controlled Diabetes Mellitus having HbA1C of 7.5%
6. Patients who have a past history of any type of heart disease or stoke.
7. Patients with any hepatic or renal disorder, with liver enzymes twice the normal or S. creatinine 1.4 mgm.
8. 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Relief in Signs & Symptoms (pain and associated complaints) of the disease by –
1. Change in the VAS score
2. Change in the percentage score of Northwick Park Neck Pain Questionnaires. |
1. Change in the VAS score from the baseline to the 14th and 21st day.
2. Change in the percentage score of Northwick Park Neck Pain Questionnaires from the baseline to the 14th and 21st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in health status by SF 36 Questionnaire |
•SF-36 QOL assessment for any improvement from the baseline to the 14th day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "59"
Final Enrollment numbers achieved (India)="59" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/11/2015 |
| Date of Study Completion (India) |
19/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title of Study : EVALUATION OF THE EFFECT OF JAMBEERA PINDA SWEDA IN CERVICAL SPONDYLOSIS WRT CLINICAL SYMPTOMATOLOGY
Primary Objective
To evaluate the effect of JambeeraPinda Sweda in the management of Sign and symptoms of cervical spondylosis.
Secondary Objective
To observe the changes in the quality of life of the study participants by using SF-36 Questionnaire.
OUTCOMES
Primary outcome
· Relief in Signs & Symptoms (pain and associated complaints) of the disease by –
1. Change in the VAS score from the baseline to the 14th and 21st day.
2. Change in the percentage score of Northwick Park Neck Pain Questionnaires from the baseline to the 14th and 21st day.
Secondary outcome
· SF-36 QOL assessment for any improvement from the baseline to the 14th day.
Treatment Period- 14 Days
Follow up period – 7 Days without treatment after the procedure (on 21st Day).
TREATMENT PROCEDURE
1-14 days – Jambeera PindaSweda in the Morning.
JAMBEERA PINDA SWEDA
The Jambeerapindasweda refers to the sudation performed by specially prepared bundles of Jambeera (citru acida) fruit pieces.
Material required:
Ingredients:
1. Jambeera (chopped in to pieces)- 750 gm.
2. Saindhava- 30gm
3. Turmeric powder- 60gm
4. RasnadiChurna- 5g.
5. Mahanarayan oil : For abhyanga- 100ml.
: For frying the ingredient-100ml.
: For reheating the Potali- Q.S
6. ksheerbala oil for talam-10ml
Preparation of potali:
Sliced lemon and other ingredients fried in 100 ml mahanarayan taila till the brown color appears. Then it should be divided in to 4 equal parts and made in to potalis accordingly.
Preoperative Procedure:
The Patient should be seated with leg extended on the droni and talam is applied with Ksheerabala taila.
Procedure:
Abhyanga should be performed with Ksheerabala taila. Out of the four Potalis ,the two potalis should be heated up to 40-450c by keeping on the hot pan containing Mahanarayan oil. These potalis are applied to the patients as per the general procedure for about 30-45 minutes.
Post operative Procedure:
After the procedure body should be wiped with clean towel, talam should be removed and Rasnadichoorna should be applied. The patient should be advised to take complete rest for half to one hour.
METHODS OF ASSESSMENT
Prior to selection – (Screening)
· Informed Consent
· Eligibility evaluation
· Physical examination
· Visual Analogue Scale (VAS)
· Laboratory Investigations
· Digital X-ray Cervical Spine AP, Lateral and Oblique View.
During Selection-(Baseline o Day)
· General information-(Personal Identification and Demographic profile)
· Medical history, General Physical and Systemic examination
· Physical examination and clinical assessment
· Visual Analogue Scale (VAS)
· Northwick Park Neck Pain Questionnaire.
· SF36 Questionnaire.
At the end of 7th day (during treatment)
· Physical examination and clinical assessment
· Visual Analogue Scale (VAS)
· Northwick Park Neck Pain Questionnaire.
At the end of the treatment i.e. 14th day
· Physical examination and clinical assessment
· Visual Analogue Scale (VAS)
· Northwick Park Neck Pain Questionnaire.
· SF36 Questionnaire.
At the end of 21st Day (Follow up without treatment)
· Physical examination and clinical assessment
· Visual Analogue Scale (VAS)
· Northwick Park Neck Pain Questionnaire. |