| CTRI Number |
CTRI/2023/07/054601 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Peechu(enema)with otradam(fomentation) for Mulangaal Vatham(osteoarthrits) |
|
Scientific Title of Study
|
An Open,Non Randomised Single Arm Single centric Clinical Trial to determine the Therapeutic effectiveness of Peechu Thearapy(medicated enema) & Mulangaal Vatha Otradam (Fomentation) in the management of Azhal Keelvayu (osteoarthritis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
N Sivamanikandan |
| Designation |
MD(S)PG Scholar |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room no 14,department of puramaruthuvam, national institute of siddha, tambaram santorium, chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
6380048976 |
| Fax |
|
| Email |
drshivamani1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DPeriyasami |
| Designation |
Associate professor |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room no 14,department of puramaruthuvam, national institute of siddha, tambaram santorium, chennai-47
Room no 14,department of puramaruthuvam, national institute of siddha, tambaram santorium, chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7358481734 |
| Fax |
|
| Email |
sami2011nis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DPeriyasami |
| Designation |
Associate professor |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room no 14,department of puramaruthuvam, national institute of siddha, tambaram santorium, chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7358481734 |
| Fax |
|
| Email |
sami2011nis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss Pandidhar Hospital
National Institute of Siddha
Tambaram sanatorium
Chennai 600 047 |
| 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 N Sivamanikandan |
Ayothidoss Pandithar Hospital |
Room no.14 Department of Puramaruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai.
Kancheepuram
TAMIL NADU |
6380048976
drshivamani1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Peechu and otradam |
Peechu for 3 days
Rest for 1 day
Otradam for 6 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
A] Patients who will be fulfill any of the following criteria will be included in the
Age: 30- 70Yrs Sex – Both male and female
B] Patients who will be having classical symptoms of pain &swelling of knee
joints, stiffness & restricted movements.
C] X-ray knee joint showing osteoarthritis
D] Willing to give blood samples before and after treatment.
E] Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during
10 days but can opt out of the trial of his/her own conscious discretion.
F] Patients who are willing to take radiological investigations.
Patient having clinical symptoms of difficulty in walking, stiffness, tenderness in knee Joint |
|
| ExclusionCriteria |
| Details |
Rheumatoid arthritis
Gouty arthritis
Tubercular arthritis
Any other serious systemic illness
Cardiac disease
Chronic kidney disease
Liver diseases
Intestinal disease
Having piles and fistula
Patient not willing for peechu therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The reduction in pain & restricted movements which was measured using goniometer & spadi index |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2023 |
| Date of Study Completion (India) |
15/08/2024 |
| Date of First Enrollment (Global) |
10/07/2023 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An open,Non Randomised,Single arm,Single centric clinical trial to determine the therapeutic effectiveness of Peechu therapy (medicated enema) and Mulangaal vatha otradam (fomentation) in the management of Azhal Keelvayu (Osteoarthritis). Patients will be enrolled based on inclusion and exclusion criteria. Then the external therapy Peechu and Mulangaal vatha otradam will be given for 10 days and followed in puramaruthuvam OPD. |