| CTRI Number |
CTRI/2025/01/078849 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Panchakarma Procedure And Ayurvedic Medicine In The
Management of Sirajgranthi W.S.R To Varicose Veins. |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Jalaukavacharna With And Without Local Application Of Mahavajraka Tail In The Management Of Sirajgranthi W.S.R To 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 Rohit |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Gurdev Nagar, Jalandhar (Punjab), Pincode- 144008, India
Jalandhar
PUNJAB
144008
India |
| Phone |
7009639796 |
| Fax |
|
| Email |
wandrawrohit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parveen Kumar |
| Designation |
Associate Professor |
| Affiliation |
Dayanand Ayurvedic College |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Gurdev Nagar, Jalandhar (Punjab), Pincode- 144008, India
Jalandhar
PUNJAB
144008
India |
| Phone |
7589303536 |
| Fax |
|
| Email |
drparv1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Gurdev Nagar, Jalandhar (Punjab), Pincode- 144008, India
Jalandhar
PUNJAB
144008
India |
| Phone |
7009639796 |
| Fax |
|
| Email |
wandrawrohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College, Mahatma Hansraj Marg, Jalandhar
(Punjab), Pin Code- 144008, India |
|
|
Primary Sponsor
|
| Name |
Dayanand Ayurvedic College |
| Address |
Dayanand Ayurvedic College, Mahatma Hansraj Marg, Jalandhar
(Punjab), Pin Code- 144008, India |
| 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 Rohit |
Dayanand Ayurvedic College And Hospital |
Department Of Panchakarma,
Mahatma Hansraj Marg, Jalandhar (Punjab), Pincode- 144008, India
Jalandhar
PUNJAB |
7009639796
wandrawrohit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAC Institutional Ethical Committee |
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: Mahavajraka Taila, Reference: Ashtanga Hridyama, Chikitsasthana, Kushtha Chikitsa -19/81-82, Route: Topical, Dosage Form: Taila, Dose: 00(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with classical signs and symptoms of Sirajgranthi.
2. Subjects between 18 years to 65 years.
3. Any gender willing and able to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects having chronicity more than 10 years.
2. Pregnant women and lactating women will be excluded.
3. Subjects having any other major complicated diseases like Diabetes Mellitus, Cardiac Diseases, Tuberculosis, HIV, HCV, HBsAg.
4. Subjects diagnosed with Venous Ulcers, Deep Vein Thrombosis, Anemia, Thrombocytopenia will be excluded.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Following symptoms will be assessed for the reduction in their severity:
1. Shoola (Pain in Lower Limbs)
2. Kandu (Itching)
3. Daha (Burning Sensation)
4. Shotha (Oedema)
5. Sirakunchana (Tortuosity of Veins)
6. Skin Changes |
On Day - 0, 10th, 20th, 30th and 45th Day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant Improvement in the objective parameters. |
On Day - 0, 10th, 20th, 30th and 45th Day.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| 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)
|
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
|
The total of 60 patients will be selected who are between age group of 18 to 65 years of either sex who are diagnosed with Sirajgranthi on the basis of sign and symptoms. Patients will be divided into two groups (Trial Group A and Trial Group B). Group A will be intervene with Jalaukavcharna and Group B will be intervene with Jalaukavcharna along with local application of Mahavajraka Tail and conduct a clinical study - To evaluate the efficacy of Jalaukavcharna in the management of Sirajgranthi w.s.r to Varicose Veins,To evaluate the efficacy of Jalaukavcharna along with local application of Mahavajraka Tail in the management of Sirajgranthi w.s.r to Varicose Veins, To evaluate the difference of efficacy of Jalaukavcharna with and without local application of Mahavajraka Tail in the management of Sirajgranthi w.s.r to Varicose Veins.
|