| CTRI Number |
CTRI/2019/02/017617 [Registered on: 12/02/2019] Trial Registered Prospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate and compare the pain relieving effect of medicated oil enema and Troyodashang Guggulu in the management of Neck Pain in patients with Cervical Spondylosis. |
|
Scientific Title of Study
|
A Comparative Study to evaluate the Shoolaghna (Analgesic) effect of Ksheerbala tail Matra Basti and Trayodashang Guggulu in the management of Greeva Sandhigata Vata (Cervical Spomdylosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pragati Chaudhary |
| Designation |
PG Scholar |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Panchkarma
Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi
South West
DELHI
110073
India |
| Phone |
8860898819 |
| Fax |
|
| Email |
pragatichaudhary1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Katara |
| Designation |
Assistant Professor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Panchkarma
Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi
South West
DELHI
110073
India |
| Phone |
9910430500 |
| Fax |
|
| Email |
drpankajkatara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Katara |
| Designation |
Assistant Professor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Panchkarma
Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi
South West
DELHI
110073
India |
| Phone |
9910430500 |
| Fax |
|
| Email |
drpankajkatara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar, Najafgarh,New Delhi-110073 |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar, Najafgarh
New Delhi-110073 |
| Type of Sponsor |
Government medical college |
|
|
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 Pragati Chaudhary |
Ch. Brahm Prakash Ayurved Charak Sansthan |
Panchkarma Therapy Section Room No-238
Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi
South West
DELHI |
8860898819
pragatichaudhary1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ksheerbala Tail Matra Basti |
72 ml once a day for 10 days |
| Comparator Agent |
Trayodashang Guggulu |
500 mg twice a day after meals for 10 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 20 years and less than 60 years of age
2. Patients presenting in OPD and IPD of CBPACS with clinical features of Greeva Sandhigata Vata as described in classical texts.
|
|
| ExclusionCriteria |
| Details |
1. Any acute condition of cervical spine like, injury, fractures.
2. Acute or chronic infections of spine
3. Carcinoma of cervical spine
4. Rheumatoid Arthritis, SLE, Ankylosing Spondylosis.
5. Any recent cervical surgery, implanted instrumentation or prosthesis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Neck Disability Index |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Visual Analogue Scale of Pain |
10 days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/02/2019 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is the open label parallel group trial comparing the analgesic effect of Kheerbala tail Matra Basti and Trayodashang guggulu in the management of Greeva Sandhigata Vata (Cervical Spondylosis). In one group Ksheerbala tail matra basti will be given in the dose of 72ml and in another group trayodashang guggulu will be given in a dose 1g daily for 10 days. The primary outcome is improvement in Neck Disability Index and secondary outcome is improvement in Visual Analogue Scale of pain. |