| CTRI Number |
CTRI/2025/05/087699 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of varicose vein disease which presents with swollen,twisted veins,bulging blue or purple lines on the legs using ayurvedic treatments |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of sahacharadi kashaya with vasaguduchyadi kashaya preceded by sahacharadi taila matrabasti in siraja granthi vis - a - vis Varicose veins |
| 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 Lalita Suranagi |
| Designation |
PG Scholar |
| Affiliation |
Government ayurveda medical college Mysuru |
| Address |
Department of kayachikitsa OPD 10
Government Ayurveda medical college New sayyaji rao road near vishweshwaraya circle Mysuru Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
7975673707 |
| Fax |
|
| Email |
lalitasuranagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mythrey R C |
| Designation |
Professor and Head of the department |
| Affiliation |
Government ayurveda medical college Mysuru |
| Address |
Professor and Head of the department of Kayachikitsa
OPD 10
Government Ayurveda medical college New sayyaji rao road near vishweshwaraya circle Mysuru Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
9513199733 |
| Fax |
|
| Email |
mythreyrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalita Suranagi |
| Designation |
PG Scholar |
| Affiliation |
Government ayurveda medical college Mysuru |
| Address |
PG Scholar department of kayachikitsa OPD 10
Government Ayurveda medical college New sayyaji rao road near vishweshwaraya circle Mysuru Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
7975673707 |
| Fax |
|
| Email |
lalitasuranagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical college Mysuru new sayyaji rao road vishweshwaraya circle mandi mohalla Mysuru Karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
Dr Lalita Suranagi |
| Address |
Dr Lalita Suranagi
PG Scholar department of kayachikitsa OPD 10
Government Ayurveda medical college New sayyaji rao road near vishweshwaraya circle Mysuru Karnataka 570001
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lalita Suranagi |
Governament Hitech Panchakarma Hospital Mysuru |
Kayachikitsa OPD
Governament hitech
panchakarma hospital
stage 1 brindavan
extension KRS road
Mysore
KARNATAKA - 570016
Mysore
KARNATAKA |
7975673707
lalitasuranagi@gmail.com |
| Dr Lalita Suranagi |
Government Ayurveda Medical college Mysuru |
OPD No 10
New sayyajirao road
Vishveshwarayya circle
Mandimohalla
Mysore
KARNATAKA - 570006
Mysore
KARNATAKA |
7975673707
lalitasuranagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurveda Medical College Ethical Clearance committee Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I831||Varicose veins of lower extremities with inflammation. Ayurveda Condition: SIRAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charaka samhitha siddhisthana 4th chpater, Procedure details: 1 matrabasti per day with sahacharadi taila with the dose of 72 ml preceded by abhyanga with sahacharadi taila to udara prusta adhoshakha as purvakarma to basti)
(1) Medicine Name: Vasaguduchyadi kashaya, Reference: sahasrayoga parishista prakarana, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: CHaraka samhitha siddhisthana 4th chapter, Procedure details: 1 matrabasti per day with sahacharadi taila with the dose of 72 ml preceded by abhyanga with sahacharadi taila to udara prusta adhoshakha as purvakarma to basti)
(1) Medicine Name: Sahacharadi kashaya, Reference: Astanga hridaya chikitsa sthana 21st chapter, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with the signs and symptoms of siraja granthi vis A vis varicose veins as mentioned in textbooks will be included
Subjects of all genders of age group between 30-70 years will be included
Subjects who come under CEAP classification of varicose vein (C0-C4)(15)
subjects with symptoms of varicose vein like dull aching pain heaviness in the limb itching burning sensation and night cramps with or without reticular veins or telangiectasias visible tortuous dilated elongated veins edema and skin changes will be included
Both fresh and treated cases of Siraja Granthi will be taken for the study
|
|
| ExclusionCriteria |
| Details |
Subjects with congenital varicose vein will be excluded
Subjects diagnosed with varicose vein due to secondary causes like abdominal tumour retroperitoneal fibrosis lymphadenopathy ascites will be excluded
Subjects with complications like DVT Eczema and Venous ulcers will be excluded
Subjects with Uncontrolled Diabetes mellitus (RBS more than 250mg dL) will be excluded
Subjects with Uncontrolled Hypertension (more than140 90 mm of Hg) will be excluded.
Subjects who are unfit for Basti procedure will be excluded
Pregnant and lactating women will be excluded
Subjects diagnosed with systemic diseases that may interfere with the study will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the efficacy of sahacharadi kashaya and vasaguduchyadi kashaya preceded by sahacharadi taila matra basti in reduction of symptoms of siraja granthi i.e varicose veins through statistical tests |
At Baseline,8th Day,38th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptoms of siraja granthi i.e varicose veins like dull aching pain in lower limbs itching burning sensation tortousity of veins edema and skin pigmentation through scales of measurement symptoms |
At Baseline,8th Day,38th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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)
|
Not Applicable |
| 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
|
Varicose veins are the penalty of vertically against gravity
Varicose veins mostly occur due to incompetence of the valves of veins they being dilated tortuous elongated veins in the leg affects both the superficial as well as the deep veins Clinical features of varicose vein are dull aching pain heaviness in the limb ankle oedema darkening and pigmentation of the skin itching burning sensation and night cramps It is a common condition in India Incidence is 5 percent of adult population and the prevalence of varicose vein is 30 to 50 percentage while 25-30 percentage in women and 15percentage in men They are more common in lower limbs because of erect posture and long columns of blood has to be supported which can lead to weakness and incompetency of valves
In contemporary science, management of varicose veins includes administration of Diuretics topical steroids Ablative procedures sclerotherapy and surgery Sometimes they may lead to complications like deep vein thrombosis hematomas damage to adjacent saphenous or sural nerve infection and anaphylaxis which is a very rare but severe complication
In Ayurvedic literature it may be correlated with Sirajagranthi which presents with sampeedana (compression) sankochana(constriction) vishoshana (Dryness) and vakreekarana (Tortuosity )of Sira Treatment for this condition includes sahachara taila Pana Basti vataghna upanaha and siravyadha
Matrabasti selected for the study is indicated in vyayamasakta (debilitated due to excessive physical work) It is vataroganut (destroys vata dosha)
Sahacharadi taila selected for the study contains sahachara dashamoola lohita priyangu and is vatahara
Sahacharadi Kashaya selected for the study is vatakaphahara raktashodhaka shothahara kandughna vedanasthapaka Vasaguduchyadi kashaya contains vasa guduchi aragwadha which destroys the diseases originated from the vitiation of vata and rakta These medicinal drugs and therapeutic procedures are cost effective free of complication and helpful in the above condition Based on this the study has been taken to compare the efficacy of Sahacharadi Kashaya with Vasaguduchyadi Kashaya followed by Sahacharadi taila matrabasti in siraja granthi |