| CTRI Number |
CTRI/2024/06/068674 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
An Open Labelled Triple Arm Phase ll clinical Trial to Evaluate the Effectiveness of Siddhar yoga maruthuva muraigal and Seenthil Chooranam (Internal medicine ) in the management of Kuruthi Azhal Noi (Hypertension) |
|
Scientific Title of Study
|
An Open Labelled Triple Arm Non Randomized Phase ll Clinical Trial To Evaluate The Effectiveness of Siddhar Yoga Muraigal and Seenthil Chooranam (Internal medicine ) in the Management of Kuruthi Azhal Noi |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJerfin Js |
| Designation |
PG Scholar |
| Affiliation |
Govt siddha medical college and hospital Palayamkottai |
| Address |
PG Scholar second year
Department of Siddhar yoga maruthuvam
Govt siddha medical college and hospital
Palayamkottai
Tirunelveli District
Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9042831378 |
| Fax |
|
| Email |
yolafin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi MDS |
| Designation |
Professor and HOD |
| Affiliation |
Govt siddha medical college and hospital Palayamkottai |
| Address |
Department of Siddhar yoga maruthuvam
Govt siddha medical college and hospital
Palayamkottai
Tirunelveli District
Tamilnadu
Govt siddha medical college and hospital Palayamkottai
Tirunelveli
TAMIL NADU
62700
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi MDS |
| Designation |
Professor and HOD |
| Affiliation |
Govt siddha medical college and hospital Palayamkottai |
| Address |
Department of Siddhar yoga maruthuvam
Govt siddha medical college and hospital
Palayamkottai
Tirunelveli District
Tamilnadu
Govt siddha medical college and hospital Palayamkottai
Tirunelveli
TAMIL NADU
62700
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD Facilities and Central library of Government siddha medical college and hospital
palayamkottai 627002
Tirunelveli District
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Dr JERFIN JS |
| Address |
PG Scholar second year
Department of Siddhar yoga maruthuvam
Govt siddha medical college and hospital
Palayamkottai 627002
Tirunelveli District
Tamil Nadu
India
|
| Type of Sponsor |
Other [Self] |
|
|
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 Jerfin Js |
Government siddha medical college and hospital |
Department of Siddhar yoga maruthuvam
Govt siddha medical college and hospital
Palayamkottai 627002
Tirunelveli
TAMIL NADU |
9042831378
yolafin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R030||Elevated blood-pressure reading, without diagnosis of hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Seenthil chooranam |
1-3gm twice a day internally for 48 days |
| Comparator Agent |
Siddhar yoga maruthuvam muraigal |
Yoga therapy for 48 Days
Yoga therapy
1 Nadi Suddhi Pranayamam
2 Relaxation movements
3 Sugasanam
4 Makrasanam
5 Savasanam |
| Intervention |
Siddhar Yoga muraigal with Seenthil chooranam (Internal medicine) |
Yoga therapy for 48 days and Seenthil chooranam 1-3gm twice a day internally |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Primary hypertension
Grade 1 hypertension: SBP 140 to 159mmHg and/or DBP 90 to 99mmHg
Patients who are willing to provide blood sample for investigation before and after treatment.
Patient who are willing to sign in the consent form.
Patients who are willing to attend OPD once in 7 days.
Patients who are willing to participate in this study with the knowledge of potential risks and who are willing to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
Rheumatoid arthritis Age below 20 and above 70
SBP 160mmHg and above DBP 100mmHg and above
Secondary hypertension associated with
Liver disease
Renal disease
Cardio vascular diseases
Endocrine disorder
Retinopathy
Medications (NSAIDs, oral contraceptive pills, etc.)
Malignancy
Resistant hypertension
Alcohol abuse
Lactation and Pregnancy
Patient with any other severe systemic disorder.
cardiac disease
history of trauma
Tuberculosis
Patients with any other serious illness
Pregnancy women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:
The study aims at bringing light on the Efficacy of the long-standing traditional practice of Siddhar Yogam therapy and Seenthil Chooranam towards the management of Kuruthi Azhal Noi
|
48days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome
The positive impact of Yoga in the treatment aspect may be highlighted through this study. |
48days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| Date of Study Completion (India) |
17/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
It is an Open labelled Triple arm Non Randomised Phase ll clinical trial to evaluate the Effectiveness of Siddhar yoga maruthuva muraigal and Seenthil chooranam (internal medicine)In the management of Kuruthi Azhal Noi (Hypertension))
Dosage 1-3gm twice a day Along with siddhar Yoga maruthuva muraigal |