| CTRI Number |
CTRI/2023/08/056092 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Moxibustion on specific acupuncture points in Knee pain |
|
Scientific Title of Study
|
Effect of Moxibustion on specific acupuncture points (SP9-Yinlingchuan,ST35-Dubi,EX31-Heting,GB43-Xiaxi) for pain management in patients with Osteoarthritis of Knee(OAK)-A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1.0 |
Protocol Number |
| N/A |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR M HEMA PRIYADHARSHINI |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical college and Hospital |
| Address |
Government Yoga and Naturopathy Medical college and Hospital
Arignar Anna Indian Medicine campus Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9566586070 |
| Fax |
|
| Email |
hemamanoharan95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANGAIYARKARASI |
| Designation |
Head of the department |
| Affiliation |
Government Yoga and Naturopathy Medical college and Hospital |
| Address |
Government Yoga and Naturopathy Medical college and Hospital
Arignar Anna Indian Medicine campus Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9994709278 |
| Fax |
|
| Email |
alagarmangai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANGAIYARKARASI |
| Designation |
Head of the department |
| Affiliation |
Government Yoga and Naturopathy Medical college and Hospital |
| Address |
Government Yoga and Naturopathy Medical college and Hospital
Arignar Anna Indian Medicine campus Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9994709278 |
| Fax |
|
| Email |
alagarmangai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical college and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical college and Hospital |
| Address |
Arignar Anna Indian medicine campus,Arumbakkam,Chennai -600106 |
| 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 M HEMA PRIYADHARSHINI |
Government Yoga and Naturopathy Medical college and Hospital |
Department of Acupuncture and Energy Medicine, PG Block, Room number-2, Arignar Anna Indian medicine campus, Arumbakkam, Chennai- 600106
Chennai
TAMIL NADU |
9566586070
hemamanoharan95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical college and Hospital, Chennai Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Moxibustion |
Study group: Moxibustion at Sp 9, St 35, Ex 31 and GB 43 for 2 minutes in each point in case of unilateral Osteoarthritis of knee or 1 minute in each point in case of bilateral Osteoarthritis of knee for 10 days with 2 days interval after the first 5 days of Intervention.
|
| Comparator Agent |
Normal routine treatment without moxibustion |
No intervention |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Both genders who were diagnosed with osteoarthritis of Knee
2.Patients diagnosed with OAK either unilaterally or bilaterally
3.Age group between 40 and 75 years
4.Patients who are willing to participate in the study.
5.Patients diagnosed either only with OAK and /or also with other systemic illness
|
|
| ExclusionCriteria |
| Details |
1.Patients with end organ damage
2.Pyrophobia
3.Woman who are pregnant, lactating and menstruating.
4.Patients who are hypersensitive to heat
5.Patients participating in other studies
6.Known case of Diabetic neuropathy, fever, open wounds
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Pain severity using the WOMAC Scale & VAS Scale before & after moxibustion intervention |
10 days with 2 days break after first 5 days of moxibustion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Range of Motion using Goniometer before & after moxibustion intervention |
10 days with 2 days break after first 5 days of moxibustion |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
09/08/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be undertaken at the Government Yoga and Naturopathy Medical college & Hospital, Chennai and is a randomized parallel group to analyse the effect of Moxibustion on specific acupuncture points (Sp 9- Yinlinguan, St 35- Dubi, Ex 31- Heting, Gb 43- Xiaxi) for pain management in patients diagnosed with Osteoarthritis of Knee. The primary outcome is assessment of pain severity using the WOMAC Scale and VAS Scale before and after moxibustion intervention. The secondary outcome is assessment of range of motion using Goniometer before and after moxibustion intervention. |