| CTRI Number |
CTRI/2021/07/035265 [Registered on: 29/07/2021] Trial Registered Prospectively |
| Last Modified On: |
28/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
SIDDHAR YOGAM AND INJI CHOORANAM FOR KNEE OSTEOARTHRITIS TREATMENT |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL TRIAL OF SIDDHAR YOGAM AND INJI CHOORANAM (INTERNAL) IN THE MANAGEMENT OF AZHAL KEEL VAYU (OSTEOARTHRITIS OF KNEE JOINT) |
| 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 DHIVYA BHARATHI |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
ROOM NO 3A
AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
CHENNAI
ROOM NO 3A
AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9677787331 |
| Fax |
|
| Email |
dbidhivya16296@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V MAHALAKSHMI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room no 3, Dept. of Sirappu Maruthuvam, AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
CHENNAI
ROOM no 3A, Dept. of Siddhar Yoga Maruthuvam, AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9940668576 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S DHIVYA BHARATHI |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
ROOM NO 3A
AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
CHENNAI
ROOM NO 3A
AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9677787331 |
| Fax |
|
| Email |
dbidhivya16296@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA |
|
|
Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
NATIONAL INSTITUTE OF SIDDHA
CHENNAI |
| 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 |
| Dr S DHIVYA BHARATHI |
AYOTHIDOSS PANDITHAR HOSPITAL, National Institute of Siddha |
Room no 3A, Dept. of Siddhar Yoga Maruthuvam,
Kancheepuram
TAMIL NADU |
9677787331
dbidhivya16296@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
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 |
| Comparator Agent |
INJI CHOORANAM |
1500mg bid with water for 45 days |
| Comparator Agent |
SIDDHAR YOGAM |
33 - 42 mins, 7 days once for 45 days (7 sittings) |
| Intervention |
SIDDHAR YOGAM AND INJI CHOORANAM |
Inji choornam - 1500mg bid with water for 45 days.
Siddhar Yogam - 33 - 42 mins, 7 days once for 45 days (7 sittings) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Age: 30 - 65years
• Sex: male, female and transgender
• Patients having the symptoms of pain, tenderness, stiffness, restricted movements, swelling and crepitation in knee joint.
• Patient willing to give blood sample for laboratory investigation.
• Patient willing to undergo radiological investigation (x-ray knee joint).
• Patient willing to sign the informed consent.
|
|
| ExclusionCriteria |
| Details |
• Psoriatic arthritis
• Rheumatoid arthritis
• Pregnancy and lactation
• Coronary artery diseases
• Diabetes mellitus
• Uncontrolled hypertension
• Recent surgery or trauma
• Patient with any other serious illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the trial is to access the reduction in the symptoms of knee osteoarthritis by WOMAC Scale (Western Ontario and McMaster Universities Osteoarthritis Index) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to evaluate the therapeutic efficacy of Siddhar Yogam and Inji chooranam (internal)
in the management of Azhal keel vayu
(Osteoarthritis of knee joint). The objective of the study is to study the Siddha
basic principles relevant to the disease. The justification of the study is, the selected Yoga
postures might focus on flexibility of the joint and increased blood flow in
that affected area, presumably by aligning knee joints. Many clinical research
studies showed that the selected Yoga postures are
effective and safe in the management of Azhal
keel vayu (Osteoarthritis). The major ingredient in the formulation Inji chooranam is Inji (Zingiber officinale) is a kayakarpa (Rejuvination) medicine which
is effective in the management of old age problems like Osteoarthritis. Most of the other ingredients of Inji chooranam have anti-inflammatory, anti-oxidant, analgesic and anti-arthritic
activities. 90 selected patients will be divided randomly and grouped into 3 groups.
GROUP-A : 30 patients with Yogam only
GROUP-B : 30 patients with Inji chooranam only.
GROUP-C: 30 patients will be treated with Yogam and Inji chooranam.
Before starting the
treatment, purgation will be given with Meganatha
kuligai-2 tablets (130 mg) with warm water in empty stomach at early
morning for balancing the deranged Uyir thathukal
and advised to take rest on next day. The administration of trial drug Inji chooranam (internal) and Yogam
therapy will be started continuously for 45 days to the patients according to
the group.
Yogam procedures
will be taught and advised to practice continuously for 7 days. The enrolled
patients should visit the hospital once in 7 days upto 45 days. In each visit, clinical
assessment will be done and prognosis will be noted. Laboratory investigations will
be done before and after
treatment. Radiological investigations will be done before enrolling the
Patient into study. After completion of the trial period, the trial patients
will be followed for next two months to observe any recurrence of symptoms. The outcome of the trial will be accessed by WOMAC
Scale (Western Ontario and McMaster Universities Osteoarthritis Index).
|