| CTRI Number |
CTRI/2022/02/040038 [Registered on: 04/02/2022] Trial Registered Prospectively |
| Last Modified On: |
03/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on THAZUTHALAI ILAI CHOORANAM in the management of KUMBAVADHAM( PERIARTHRITIS) |
|
Scientific Title of Study
|
A prospective open labelled non randomized phase II clinical trial of THAZHUTHALAI ILAI CHOORANAM in the management of KUMBAVADHAM (PERIARTHRITIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mani bharathi M |
| Designation |
PG Scholer |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG department of Pothumaruthuvam OP no 10,Government Siddha Medical college and Hospital, Palayamkottai
PG Department of Pothumaruthuvam OP no 10,Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9751982937 |
| Fax |
|
| Email |
manibharathibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr A Manoharan MDs ph D |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothumaruthuvam,OP NO 10,Government Siddha Medical College and Hospital, Palayamkottai.
PG Department of Pothumaruthuvam,OP no10 ,Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDr A Manoharan MDs ph D |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothumaruthuvam,OP no 10,Government Siddha Medical College and Hospital, Palayamkottai.
PG Department of Pothumaruthuvam,OP no 10, Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| ›OPD and IPD facilities and Central Library of Government Siddha Medical College and Hospital palayamkottai, Tirunelveli |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli |
| 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 Mani bharathi |
Government Siddha Medical College and Hospital |
PG department of pothumaruthuvam, OP no 10, Palayamkottai, Tirunelveli 627002
Tirunelveli
TAMIL NADU |
9751982937
manibharathibsms@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: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
0 |
| Intervention |
THAZHUTHALAI ILAI CHOORANAM |
2g/twice a day/orally with Hot water,45 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having main symptoms of shoulder pain, numbness, wasting in the shoulder region and arms, restricted movement of upperlimbs,loss of abduction and forward flexing, stiffness of the shoulder joint
2.Diabetes mellitus
3.patient willing for doing laboratory investigations and X ray, imaging |
|
| ExclusionCriteria |
| Details |
1.Rheumatoid arthritis
2. Ischemical heart disease
3.Hypertension
4. Pregnancy and lactating mother
5.Recent shoulder dislocation
6. Sub acromial bursitis |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
If during treatment or after treatment Redution of the signs and symptoms of
1.shoulder joint pain
2.shoulder stiffness
3.Inability to raise arm
4.Limited shoulder mobility and wasting in shoulder region and arms and numbness
5.Radiating pain down arm
6.Restricted movements of upperlimbs.
7. Loss of abduction and forward flexing and external rotation and achieving better Oxford shoulder score (40-48) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the biochemical physico-chemical analysis of clinical trail drug
2. To evaluate the antimicrobial activity of trail drug
3.To evaluate the safety profile for acute and subacute toxicity of the trail drug Thazhuthalai ilai chooranam
4. To Evaluate pharmacological analysis of the clinical trail drug
5. To evaluate siddha parameters and modern parameters during the treatment of kumbavadham with trail drug
6. To evaluate the statistical analysis of the clinical trail drug Thazhuthalai ilai chooranam
7. To evaluate the powder of microscopic study and HTPLC of the trail drug |
45days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
12/02/2022 |
| 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 study is a prospective open labelled non randomized phase II clinical trail on Thazhuthalai lllai chooranam in the management of Kumbavadham( Periarthritis). The trail drug will be administered at the dose of 2gm/Twice a day A/F for 45 days along with hot water adjuvant in 40 patients. The trail period of 12 months will be carrying out in Government Siddha Medical College and Hospital, palayamkottai, Tirunelveli. The primary outcome will be evaluation of therapeutic efficacy of trail drug THAZHUTHALAI ILAI CHOORANAM. The secondary outcome will be evaluation of siddha parameters, assessment of safety profile of trail drug, assessment of pharmacological and biochemical parameters of trail drug. In case any adverse event (AE) is noticed and it will be referred to pharmacovigilence department of SCRI. Further management of patient will be given in OPD facility.
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