| CTRI Number |
CTRI/2024/10/074994 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study efficacy of kanchnar guggulu along with siravedha in siraj granthi |
|
Scientific Title of Study
|
RANDOMZED OPEN CONTROLLED CLINICAL TRIAL OF SIRAVEDHA
WITH AND WITHOUT INTERNAL ADMINISTRATION OF
KANCHANARA GUGGULU IN SIRAJAGRANTHI |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijayalaxmi Popat Kale |
| Designation |
Post graduate student |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
| Address |
Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7391905153 |
| Fax |
|
| Email |
kaleusha7000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akbar Walandkar |
| Designation |
HOD of shalya Tantra Department |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
| Address |
Department of Shalyatantra Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Tal Walwa Dist Sangli Pin code 416301
Sangli
MAHARASHTRA 416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akbar Walandkar |
| Designation |
HOD of shalya Tantra Department |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
| Address |
Department of Shalyatantra Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Tal Walwa Dist Sangli Pin code 416301
Sangli
MAHARASHTRA 416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research centre Ashta Tal walwa Dist Sangli Maharashtra India pin code 416301
|
|
|
Primary Sponsor
|
| Name |
Hon shri annasaheb dange ayurveda medical college and post graduate research centre Ashta |
| Address |
Hon shri Annasaheb Dange Ayurved Medical College and Post graduate research center Ashta Tal-Walwa Dist-Sangli Pin code 416301 |
| Type of Sponsor |
Private 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 Vijayalaxmi popat kale |
Hon shri Annasaheb Dange Ayurvedic Medical college and Dhanwantari Hospital ashta |
Opd no 13 shalyatanra opd ground floor Dhanwantari Ayurvedic Hospital Ashta Taluka Walwa District Sangli Sangli MAHARASHTRA
Sangli
MAHARASHTRA |
7391905153
kaleusha7000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Hon Shri Annasaheb Dange Ayurvedic Medical college and post graduate research center Ashta |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kanchanara guggulu, Reference: Sharagdhar Sharangdhar Samhita Marathi commentary choukhamba prakashan Varanasi 2009 choukhamba prakashan chapter 11 verse 23 and24 and25 and26 and 27pg 161, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Sushrut sanhita pv sharma english commentary chaukhambha prakashan varanasi 9th edition sutrasthan chapter 11 verse32 page 38, Procedure details: Siravedha done in 2 settings with a gap of 15 days in between
After palpating sira vein punctured with scalp vein set & blood collected in glass jar )
(1) Medicine Name: Kanchanar guggulu, Reference: Sharagdhar, Sharangdhar Samhita Marathi commentary choukhamba prakashan Varanasi 2009 choukhamba prakashan chapter 11 verse 23and24and25and26and27pg 16, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 20-70 years (as this condition is
commonly noted in these age group), irrespective of sex, caste
and religion was selected Patients who are fit for Siravedha.
Patients suffering from primary varicose veins |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases interfering with the treatment Congenital varicose veins.
Siravedha anarhas. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of subjective paramenters like shool kandu daha and objective parameters like shotha sira vakreekarana twak vaivarnyata |
Assessment or improvement of parameters will be done on 15th 30th and 45th day of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of clinical features, subjective and objective parameters |
Assessment of improvement of features will be done on 15th 30th and 45th day |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
19/10/2024 |
| 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 Yet Recruiting |
| 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 vein is a disease with prevalence of 5% It is a lifestyle disease due to prolonged standing This disease is the most common among peripheral vascular diseases The use of elastic compression stockings is advised for varicose vein. Recurrence has been reported after sclero-therapy and surgeries like stripping. The treatment prevailing does not satisfy both the surgeons and the sufferers Here a humble step has been taken which is safe and cheap, expecting to satisfy the surgeons as well as patients Drog dose -250 mg tablet BID Follow up on 15th 30th and 45th day Study duration 1 year 6 months Duration of treatment 30 days
|