| CTRI Number |
CTRI/2021/02/031407 [Registered on: 19/02/2021] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Trial to evaluate the efficacy of Siddha Varmam Therapy (SVT) as an addon therapy to Biomedicine among Diabetes patients |
|
Scientific Title of Study
|
Randomized double arm Clinical Trial to evaluate the efficacy of Siddha Varmam Therapy (SVT) among Type II Diabetes Mellitus patients attending Madhumegam Special OPD, SCRU, Tirupati |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRajalakshmi |
| Designation |
Research Associate |
| Affiliation |
Siddha Clinical Research Unit, Tirupati, Under Central Council for Research in Siddha, |
| Address |
Dr. S. Rajalakshmi,
Research Associate, Room no.2, OPD, Clinical Department,
Siddha Clinical Research Unit, Under Central Council for Research in Siddha,
Tirupat, Andra Pradesh, India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
09585600845 |
| Fax |
|
| Email |
drrajishine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajalakshmi |
| Designation |
Research Associate |
| Affiliation |
Siddha Clinical Research Unit, Tirupati, Under Central Council for Research in Siddha, |
| Address |
Dr. S. Rajalakshmi,
Research Associate, Room no.2, OPD, Clinical Department,
Siddha Clinical Research Unit, Under Central Council for Research in Siddha,
Tirupat, Andra Pradesh, India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
09585600845 |
| Fax |
|
| Email |
drrajishine@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRajalakshmi |
| Designation |
Research Associate |
| Affiliation |
Siddha Clinical Research Unit, Tirupati, Under Central Council for Research in Siddha, |
| Address |
Dr. S. Rajalakshmi,
Research Associate, Room no.2, OPD, Clinical Department,
Siddha Clinical Research Unit, Under Central Council for Research in Siddha,
Tirupat, Andra Pradesh, India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
09585600845 |
| Fax |
|
| Email |
drrajishine@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Director General, Central council for Research in Siddha, Chennai, Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Central council for Research in Siddha |
| Address |
Central council for Research in Siddha, Anna hospital campus, Arumbakkam, Chennai, Tamilnadu-600106 |
| Type of Sponsor |
Research institution |
|
|
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 Rajalakshmi |
OPD, Siddha Clinical Research Unit, Tirupati. |
OPD, Room no. 2, clinical Department,
Siddha Clinical Research Unit, Under Central Council for Research in Siddha,
Tirupat, Andra Pradesh, India
Chittoor
ANDHRA PRADESH |
9585600845
drrajishine@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics committee, Siddha Clinical Research Unit, Tirupati, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Siddha Varmam Therapy alone. |
Patient receive Siddha Varmam Therapy alone three days once for the period of 3 months |
| Comparator Agent |
Siddha Varmam Therapy and Biomedicine |
Patient receive Siddha Varmam Therapy three days once for the period of 3 months along with the standard Biomedicine. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in Age between 30-60 years of both gender
2. Patients having Fasting blood sugar ranging above 100 and below 200 mg/dl
3. HbA1C ranging above 5.5% below 7.5%
|
|
| ExclusionCriteria |
| Details |
1. Subjects with the age below 30 years and above 60 years are to be excluded from the study.
2. Pregnant women and planning to be pregnant within six months and lactating mother.
3. Known case of
i. Malignancy
ii. Accelerated Hypertension
iii. Coronary artery disease
iv. CNS disorders
v. Type I Diabetes mellitus
vi. Acute infection or fever
vii. Chronic viral hepatitis or HIV-infection
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Efficacy of Siddha Varmam therapy on Type II Diabetes Mellitus patients in reducing the FBS, PPBS, HbA1c at baseline, 30, 60, 90 days of treatment. |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Safety of Siddha Varmam therapy on Type II Diabetes Mellitus patients is assessed by comparing Liver function Test and Renal function Test at baseline, 30, 60, 90 days of treatment.
2. Siddha diagnostic tool is validated and tested at baseline, 30, 60, 90 days of treatment.
|
9 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
22/02/2021 |
| Date of Study Completion (India) |
02/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In
Siddha system of medicine varmam is one unique method of physical manipulation
used for various ailments. In recent years there are many clinical trials
conducted on Varmam therapy to treat diseases such as osteoarthritis, periarthritis,
cervical spondylosis, lumbar spondylosis, autism.
But still now no attempts were made to prove its effect in Diabetes. This study
aims to validate the SVT in Type II Diabetes Mellitus patients. The objective
of the study is to evaluate the hypoglycemic activity of Siddha varmam therapy
(SVT) among Type II diabetes Mellitus patients in reducing the FBS, PPBS, HbA1c.
SVT manipulation done by trained siddha varmam doctor on three days once for
the period of 3 months. The outcome of the study is assessed by Efficacy
of Siddha Varmam therapy on Type II Diabetes Mellitus patients in reducing the
FBS, PPBS, HbA1c at baseline, 90 days of treatment. There are 15 patients
recruited in Arm 1, 15 patients recruited in arm-2. The study completed its
recruitment on 02-08-2023. |