| CTRI Number |
CTRI/2021/04/032911 [Registered on: 19/04/2021] Trial Registered Prospectively |
| Last Modified On: |
17/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Other (Specify) [Curative and Promotive] |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Nasya and Greevabasti in Cervical spondylosis |
|
Scientific Title of Study
|
A Clinical Study to evaluate the combined effect of karpasasthyadi Taila Nasya and Greevabasti in the management of Greevastambha wsr to Cervical Spondylosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Pushpinder Singh |
| Designation |
H. O. D of Panchkarma Department |
| Affiliation |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital, Distt kangra H.P.(176117) |
| Address |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital, Distt kangra H.P.(176115)
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital, Distt kangra H.P.(176115)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8580789117 |
| Fax |
|
| Email |
drpushpinderpk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Pushpinder Singh |
| Designation |
H. O. D of Panchkarma Department |
| Affiliation |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital, Distt kangra H.P.(176117) |
| Address |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital, Distt kangra H.P.(176115)
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital, Distt kangra H.P.(176115)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8580789117 |
| Fax |
|
| Email |
drpushpinderpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhee Thakur |
| Designation |
Pg scholar |
| Affiliation |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital, Distt kangra H.P.(176115) |
| Address |
Panchkarma Department Rajiv Gandhi Post Graduate Ayurvedic College and Hospital, Distt kangra H.P.(176115)
Panchkarma Department Rajiv Gandhi Post Graduate Ayurvedic College and Hospital, Distt kangra H.P.(176115)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219213873 |
| Fax |
|
| Email |
nidhee1995thakur@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/S Shashi Pal Gourav kumar, khoon Bazar Paprola Teh. Baijnath Distt. Kangra(H.P.) 176115 |
| Research Institute In I. S. M. Jogindernagar, Distt. Mandi(H.P.) |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola Distt kangra (176115) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Pushpinder Singh |
Rajiv Gandhi Ayurvedic College and Hospital |
Room no. 203 H.O.D. Department of Panchkarma, RGGPG Ayurvedic College and Hospital kangra(H.P.)
Kangra
HIMACHAL PRADESH |
8580789117
drpushpinderpk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(human) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: Greeva Stambha, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasya and Greevabasti |
Nasya - 16 drops in each nostril for 10 days
Greevabasti(local oleation in neck region) for 10 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient willing for study.
2) Patient fit for Nasya.
3) Clinical signs and symptoms with or without radiological changes of Cervical spondylosis.
|
|
| ExclusionCriteria |
| Details |
1) Patient not willing for study.
2) Patient not for for Nasya.
3) Patient with traumatic injury of cervical spine.
4) Patient suffering from neoplastic disorders.
5)Patient with major systemic disorders that may interfere with course of treatment.
6) Patient of RA and gouty arthritis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of well being |
10 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/04/2021 |
| 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="0"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
I would like to publish my trial after completion of the trial as soon as possible. Patients will be selected from campus faculty/ OPD of RGGPG Ayurvedic College and Hospital Paprola. Single group of 10 patients will be assessed on the basis of inclusion and exclusion criteria to know the combined effect of Nasya and Greevabasti in the management of Greevastambha wsr to Cervical Spondylosis. |