| CTRI Number |
CTRI/2024/03/063526 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative clinical study to evaluate the effect of Raktamokshana and Agnikarma with Arjun Ksheerpak on Varicose Vein. |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Arjun Ksheerpak with Agnikarma and Jalaukavacharan in the management of Siragranthi W.S.R. To 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 |
Manisha |
| Designation |
PhD scholar 1st year |
| Affiliation |
Madan Mohan Malviya government ayurvedic college and Hospital, Shalya Tantra Department,Room no. 05 |
| Address |
Madan Mohan Malviya government ayurvedic college and hospital, Shalya Tantra Department, Room no. 11
Udaipur
RAJASTHAN
313001
India |
| Phone |
7011376298 |
| Fax |
|
| Email |
manishashuklauk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mahesh Dixit |
| Designation |
Principal and HOD, Department of Shalya Tantra |
| Affiliation |
Madan Mohan Malviya government ayurvedic college and hospital |
| Address |
Madan Mohan Malviya government ayurvedic college and hospital, Department of Shalya Tantra, Division- Shalya tantra, Room no.11
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414245459 |
| Fax |
|
| Email |
prof.maheshdixit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha |
| Designation |
PhD scholar 1st year |
| Affiliation |
Madan Mohan Malviya government ayurvedic college and hospital |
| Address |
Madan Mohan Malviya government ayurvedic college and hospital, Shalya Tantra Department, Room no. 11
Udaipur
RAJASTHAN
313001
India |
| Phone |
7011376298 |
| Fax |
|
| Email |
manishashuklauk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya government ayurvedic college and hospital |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya government ayurvedic college and hospital |
| Address |
Madan Mohan Malviya government ayurvedic college and hospital , Udaipur Rajasthan, 313001 |
| Type of Sponsor |
Government 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 Mahesh Dixit |
Madan Mohan Malviya government ayurvedic college and hospital , udaipur |
Room no. 11, shalya opd, Madan Mohan Malviya government ayurvedic college and hospital , udaipur
Udaipur
RAJASTHAN |
9414245459
prof.maheshdixit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I00-I99||Diseases of the circulatory system. Ayurveda Condition: SIRAJAGRANTHIH, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: SIRAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Procedure Reference: Su. sutra 12/8, Procedure details: Procedure details: 5 SESSION of Agnikarma with bindudahan vishesha by Panchadhatu Shalaka at the interval of 7 days. TIME-once a day DURATION-1 month)
)
(1) Medicine Name: Arjun, Reference: Chakradatta, Hridyarog chikitsa adhyaya, shlokas no. 08,, Route: Oral, Dosage Form: Ksheerpaka, Dose: 3(g), Frequency: bd, Duration: 1 Months | | 2 | Comparator Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रकà¥à¤¤à¤®à¥‹à¤•à¥à¤·à¤£à¤®à¥/ शोणितसà¥à¤°à¤¾à¤µà¤ƒ/ असà¥à¤°à¤µà¤¿à¤¸à¥à¤°à¥à¤¤à¤¿à¤ƒ/शसà¥à¤¤à¥à¤°à | (Procedure Reference: Sushrut sutra 13/19-22, Procedure details: 5 session of Jalauka Avacharan at the interval of 7 days, Time- Once a day, Duration- 30 days)
(1) Medicine Name: Arjun, Reference: Chakradatta, Hridyarog chikitsa adhyaya, shlokas no. 08, , Route: Oral, Dosage Form: Ksheerpaka, Dose: 3(g), Frequency: bd, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with cardinal features of varicose veins |
|
| ExclusionCriteria |
| Details |
Uncontrolled diabetes mellitus.
Patient with other severe complications of varicose veins.
Any other serious systemic illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in dilatation of varicose vein. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the recurrence of vain dilatation of varicose vein. |
8 week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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="0"
Months="2"
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
|
In Ayurveda classics varicose vein
can be very much correlated with the signs and symptoms explained for Siragranthi (obstructive
circulation) and Siragata Vata. Varicose veins are enlarged, tortuous veins caused by
venous insufficiency. Acharya Bhavprakash mentioned the Sneha-abhayang, Sneha- mardan, Sneha-pralepa and Raktamokshana in context of Siragata Vata Chikitsa. Agnikarma is described in the context
of Vata
Vyadhi Chiktisa for the regulation of Sira, Snayu, Asthi, and Sandhi Vikara. Arjuna is one of the best herbs recommended for strengthening heart
muscles that can help to increase the blood flow to arteries which protect veins from
damage. Total 60 patients selected between age group 30 to 70 irrespective of
their gender, religion. |