| CTRI Number |
CTRI/2025/08/092839 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative study on Ayurvedic treatment as Jalaukavcharan and Siravyadha in patients with Varicose Vein.
|
|
Scientific Title of Study
|
Comparative study of efficacy of Jaloukavcharan and Siravyadha in Sirajgranthi W.s.r to Varicose Vein |
| Trial Acronym |
JVC and SV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anita Patel |
| Designation |
Professor |
| Affiliation |
Swami Narayan Ayurvedic College Kalol, Gandhinagar, Gujarat |
| Address |
Professor Department of Shalyatantra Swami Narayan Ayurvedic College Kalol, Gandhinagar, Gujarat
Gandhinagar Gujarat
Ahmadabad
GUJARAT
382725
India |
| Phone |
9176945090 |
| Fax |
|
| Email |
dranitasudha@swaminarayanuniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Patel |
| Designation |
Professor |
| Affiliation |
Swami Narayan Ayurvedic College Kalol, Gandhinagar, Gujarat |
| Address |
Professor Department of Shalyatantra Swami Narayan Ayurvedic College Kalol, Gandhinagar, Gujarat
Gandhinagar Gujarat
Ahmadabad
GUJARAT
382725
India |
| Phone |
9176945090 |
| Fax |
|
| Email |
dranitasudha@swaminarayanuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harmeet Kour |
| Designation |
Associate Professor |
| Affiliation |
Jammu Institute of Ayurveda and Researchl |
| Address |
Associate Professor Jammu Institute of Ayurveda and Research
Nardni Raipur Bantalab Road Jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
09697122134 |
| Fax |
|
| Email |
drharmeetkour1711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of shalyatantra, Jammu Institute of Ayurveda and Research Jammu
Pin 181123 |
|
|
Primary Sponsor
|
| Name |
Dr Harmeet Kour |
| Address |
Associate Professor Jammu institute of Ayurveda and Research Nardni Bantalab Road Jammu 181123 |
| Type of Sponsor |
Other [Self sponsor] |
|
|
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 Harmeet Kour |
Jammu Institute of Ayurveda and Research |
OPD,IPD, Department of Shalyatantra Jammu Institute of Ayurveda and Research. Nardni Raipur Bantalab Road, Jammu 181123
Jammu
JAMMU & KASHMIR |
09697122134
drharmeetkour1711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE SWAMINARAYAN UNIVERSITY KALOL |
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 | Procedure | - | raktamokshanam/ Shonitasravah/ asravisrutih/ Shastravisravanam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रविस्रावणम् | (Procedure Reference: Sushruta Samhita, Published by Chaukhamba Orientalia , Varanasi, SutraSthana Chapter 14, shlok 44, Sushruta Samhita Chaukhamba Sanskrit sansthan Varanasi , Nidan sthan Chapter 11 , shlok 3, page 268., Procedure details: Leech therapy & Siravyadha are performed as an OPD procedure at the interval of 1 week & total 4 sittings are done in the total duration of 1 month, more sittings shall be done depending upon the need.
PROCEDURE OF JALOUKAVCHARN (Group A): -
I.PURVAKARMA (Pre-Operative Procedure): -
Written consent of patient is taken.
All pre procedure investigation like – RBS, BT, CT must be done.
Patient is explained about the procedure.
All instruments required for the procedure must be prepared.
Jaloukas are activated by putting it into the haridra jal (turmeric powder).
II.PRADHANKARMA (Main Procedure): -
Jalouka are applied on the most effected site, where the maximum tortuosity & pain found.
When the jalouka attached itself to the site, wet cotton is placed over it.
Jalouka is applied there for approximately 45 minutes.
Some of jalouka detached itself & some of them are detached by applying haridra on its mouth.
After detachment of the jalouka, proper bandage is applied to avoid post procedure bleeding.
III.PASCHATKARMA (Post Procedure): -
Haemostasis is achieved.
Proper vaman of jalouka is done.
After vaman, jalouka are stored in a clean container with label of name of patient with date of procedure.
Patient are advised to take proper rest along with proper position of the limb at least for 24 hours after the procedure.
Light diet is advised to the patient.
Patient is advised to inform doctor for any kind of bleeding or complication at the site of jalouka application.
)
| | 2 | Comparator Arm | Procedure | - | Raktamokshanam/ Shonitasravah/ asravisrutih/ Shastravisravanam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रविस्रावणम् | (Procedure Reference: Acharya Sushruta : Sushruta Samhita , Published by Chaukhamba Orientalia , Varanasi , Nidan Sthan , 11th chapter, Acharya Vagbhata , Ashtang Hridya Uttartantra , Chapter 29 , Shlok 30., Procedure details: PROCEDURE OF SIRAVEDA (Group B): -
i PURVAKARMA (Pre-Operative Procedure): -
Written consent of patient is taken.
Material used like sterile cotton pads, needle of size 20 G, kidney tray, tourniquet are prepared
ii. PRADHANKARMA (MAIN PROCEDURE): -
Tourniquet is tied approximately about 7cm above the site of siravyadha.
Then, sterile needle of size 20G is introduced into the vein, after letting out of blood, the needle is taken out & simultaneously needle is introduced into the other effected veins of the lower limbs & blood is taken out after that the area is bandaged with sterile cotton pad.
Patient is advised to take rest by keeping the limb elevated for two hours & avoid prolonged standing or walking for 24 hours after the procedure.
iii. PASCHATKARMA (POST PROCEDURE): -
Haemostasis is achieved.
The diet which is neither hot nor cold & is light, which is easily digestible, that stimulates the digestion is recommended or advised to the patient.
FOLLOW UP STUDY: - After completion of the course of the treatment the patient is advised to attend the O.P.D for one month with an interval of 7 days to know whether recurrence has occurred or not.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with clinical features of varicose veins.
2 Age group of 18-70 years irrespective of gender.
3 Patient indicated for Jaloukavcharan and Siravyadha.
|
|
| ExclusionCriteria |
| Details |
1 Presence of any tumor as a cause of varicose veins.
2 Congenital disorders.
3 Blood clotting disorders.
4 Patients on prolonged anti-coagulant drugs.
5 Patients suffering from autoimmune disorders.
6 Children less than 18 or elderly above 70 years.
7 Patient not willing for leech therapy and
Siravyadha.
8 Patients having TB, severe anaemia, obesity, venous ulcer.
9 Patient contraindicated for Jaloukavcharan and Siravyadha.
10 Hb less than 10gm %.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Does Jaloukavcharan show more effect in comparison to Siravyadha in the management of Sirajgranthi (Varicose Vein) |
30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To promote the safe, cost effective and traditional treatment of management of Sirajgranthi
-To promote the innovative treatment of Sirajgranthi
-To study the Varicose vein as per modern text and Sirajgranthi as per Ayurvedic text |
Jaloukavcharan and Siravyadha locally
-4 sittings at 7 days interval(30 days)
-Follow up 30 days
-Total study duration 60 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
23/08/2025 |
| 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="2"
Months="0"
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 disease characterized by dilated, tortuous, elongated veins. it is more prevalent in females (25-30%) than males (15%). lack of proper exercise , prolonged standing or sitting, increasing age, heavy weightlifting, multiple pregnancies, high blood pressure are the predisposing factors. it is one of the common problems for which patients visit the Ayurvedic hospitals. Acharya Sushruta has described that vitiated Vat when renders in Siras it causes pain, contraction and fullness of blood vessels. This disease has been named as Kutilasira or Sirajgranthi. Acharya Sushruta has mentioned Raktmokshana in the treatment of Sirajgranthi. it is considered as Ardha Chikitsa of Shalyatantra and is said to provide immediate results. Thus Leech therapy and Siravyadha can be a cheaper and effective way to deal with Varicose vein. this treatment improve microcirculation and nutrition to sk.in and surrounding tissues, simultaneously it helps in reducing extra load on veins and blood pooling in distended vessels. Thus this study will prove to effective, safe and cost effective treatment in treating Varicose vein.
A total of 90 patients are selected and randomly divided in 2 groups.
Group 1 - 45 patients will recieve four sittings of Leech therapy (Jaloukavcharan) with a gap of one week.
Group 2 - 45 patients will be treated with Siravyadha with a gap of one week |