| CTRI Number |
CTRI/2025/02/080858 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sudy to observe the changes in the blood of Siraja Granthipatients(Variscose vein) |
|
Scientific Title of Study
|
Observational study to assess Shonita Dushti in Siraja Granthi(Varicose Vein). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Kumar S |
| Designation |
Pg Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 573201 Karnataka |
| Address |
Sri Dharmasthala Manjunatheshwara Collge of Ayurveda and Hospital Hassan 573201 Karnataka
Department of Roganidana Evam Vikriti Vijnana
II Year Pg Scholar
Hassan
KARNATAKA
573201
India |
| Phone |
9845281659 |
| Fax |
|
| Email |
pg23137@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandesh Mohan P |
| Designation |
Associate Professor |
| Affiliation |
Rajeev gandhi university of health sciences Banglore |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201 karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
7204442020 |
| Fax |
|
| Email |
drsrinanden@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandesh Mohan P |
| Designation |
Associate Professor |
| Affiliation |
Rajeev gandhi university of health sciences Banglore |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan karnataka 573201
Hassan
KARNATAKA
573201
India |
| Phone |
7204442020 |
| Fax |
|
| Email |
drsrinanden@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan karnataka 573201 |
|
|
Primary Sponsor
|
| Name |
Dr Sanjay Kumar S |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan karnataka 573201 |
| 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 Sanjay Kumar S |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan karnataka 573201 |
Diagnostic Block
Department of Roganidana evam Vikriti Vijnana
Hassan
KARNATAKA |
9845281659
pg23137@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEESRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I832||Varicose veins of lower extremities with both ulcer and inflammation. Ayurveda Condition: SIRAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the diagnostic criteria. (After C2 Grading of clinical signs CEAP classification of varicose vein)
Subjects between the age group of 20-60 years irrespective of gender.
Subjects who are willing to participate and sign the informed consent. |
|
| ExclusionCriteria |
| Details |
On Anticoagulant medication.
Bleeding disorder.
Uncontrolled diabetes.
Recent surgery or trauma within 3 months.
Pregnant and Lactating mother. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Two sample of Blood will be collected from patients of Varicose Vein one from Rakta mokshana blood and one from normal vein will be subjected for physical assessment and compared |
One day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Shonita Dushti Lakshana in subjects of Siraja Granthi using developed tool. |
One day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Dosha,Dhatu,Mala are the roots of the human body.
1 Rakta is one among the Saptadhatu. Rakta
Dhatu brings lusture to skin colour, nourishment of Mamsa Dhatu and is responsible for
Jeevanakarma2
. For every disease to manifest, Vatadi Dosha gets vitiated due to specific Nidana,
which in turn leads to vitiation of Rasa Raktadi Dhatu. Dushita Rakta results in the manifestation
of numerous diseases which can be either systemic or localised.
Siraja Granthi is caused by Vitiated Vata which causes Peedana to the Sashonita Sirajala leading
to the emergence of a Nishpurana, Neeruja Granthi referred to as Siraja Granthi.
3 From
contemporary science Siraja Granthi is analogous with Varicose vein.
Shonita Dushti Lakshana are mentioned in Brihatrayi but standardised methods for the assessment
of Shonita Dushti based on Doshadhikya in the different diseases are not developed. Understanding
the role of Shonita Dushti in Siraja Granthi can provide insights into preventive measures and
treatment strategies. Assessing Shonita Dushti in Siraja Granthi condition from an Ayurvedic
perspective can lead to the development of personalised interventions based on Shonita dusti. Hence
an attempt will be made to assess Lakshana of vitiated Shonita specifically in subjects of Siraja
Granthi to know the Dosha involved. |