| CTRI Number |
CTRI/2023/07/054725 [Registered on: 04/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Rasabhra Guggulu In Patients With Varicose Veins.
|
|
Scientific Title of Study
|
A Randomised Controlled Clinical Study To Evaluate The Effect Of Rasabhra Guggulu In
The Management Of Uttana Vatarakta 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 Riya Goyal |
| Designation |
M.D Scholar (Kayachikitsa) |
| Affiliation |
Rajiv Gandhi University Of Health Sciences,Bengaluru |
| Address |
OPD 7, Department of Kayachikitsa, Shri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
7206407772 |
| Fax |
|
| Email |
riyagoyal1010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riya Goyal |
| Designation |
M.D Scholar (Kayachikitsa) |
| Affiliation |
Rajiv Gandhi University Of Health Sciences,Bengaluru |
| Address |
OPD 7, Department of Kayachikitsa, Shri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
7206407772 |
| Fax |
|
| Email |
riyagoyal1010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Goyal |
| Designation |
M.D Scholar (Kayachikitsa) |
| Affiliation |
Rajiv Gandhi University Of Health Sciences,Bengaluru |
| Address |
OPD 7, Department of Kayachikitsa, Shri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
7206407772 |
| Fax |
|
| Email |
riyagoyal1010@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL,KUTHPADY,UDUPI |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Veerakumara K |
Shri Dharmasthala Manjunatheshwara Ayurveda Hospital,Kuthpady,Udupi |
Department Of Kayachikitsa And Manasa Roga
OPD-7 Kayachikitsa
Udupi
KARNATAKA |
9743490753
khadiravana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee Human |
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: UTTANA-VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: RASABHRA GUGGULU, Reference: BHAISHAJYA RATNAVALI,VATARAKTA CHIKITSA,CHAPTER-27 [91-97], Route: Oral, Dosage Form: Guggulu , Dose: 6000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: MEDICINE FOR PATIENTS WILL BE GIVEN IN THE FORM OF CAPSULES. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KAISHORA GUGGULU, Reference: BHAISHAJYA RATANAVALI,VATARAKTA CHIKITSA,CHAPTER-27 [98-108], Route: Oral, Dosage Form: Guggulu , Dose: 3000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: MEDICINE FOR PATIENTS WILL BE GIVEN IN FORM OF CAPSULES. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT PRESENTING WITH MORE THAN FOUR OUT OF EIGHT SIGNS AND SYMPTOMS OF UTTANA VATARAKTA/VARICOSE VEINS WILL BE INCLUDED IN THE STUDY.
KANDU-ITCHING
DAHA-BURNING SENSATION
RUK-PAIN
AAYAM-FEELING OF STRETCHING
TODA-PRICKING PAIN
SPHURANA-PULSATING SENSATION
AAKUNCHANA-CONTRACTION
SHYAVRAKTATWAK-SKIN DISCOLORATION |
|
| ExclusionCriteria |
| Details |
PREGNANT WOMEN
PROGRESSIVE GANGRENOUS CHANGES
THROMBOPHLEBITIS
BLEEDING
ACUTE FAT NECROSIS
ULCERATION
DEEP VEIN THROMBOSIS |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VCSS[VENOUS CLINICAL SEVERITY SCORE]is used to Monitor the Changes in Venous diseases before and after the treatment using Subjective Parameters like shoola,daha and Objective Parameters like Shyavraktatwak,Aakunchana. |
Time Frame [At baseline, 4 week] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disease-Specific Quality Of Life Measured by Aberdeen Varicose Veins Questionnaire [AVVQ] |
4 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| Date of Study Completion (India) |
15/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a Randomized,open label,parallel group study comparing the safety and efficacy of Controlled drug [group-A] Kaishora Guggulu 3000 mg daily and the Trial drug [group-B] Rasabhra Guggulu 6000 mg daily for 28 days for 15 patients to each groups and will be conducted in Shri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, Kuthpady,Udupi, Karnataka, India. The Primary outcome measures will be assessed through VCSS [ Venous Clinical Severity Score] Before and After the treatment using Subjective and Objective parameters. The Secondary outcome incorporate the range of signs and symptoms of chronic venous disease to characterize the severity from C0 to C6 through CEAP [ clinical,ethiologic,anatomic,pathophysiologic] classification scheme and Disease specific Quality of Life will be Measured by Aberdeen Varicose veins Questionnaire [ AVVQ]. Hence an effort has been planned through this clinical study to prove the efficacy of Rasabhra Guggulu as effective against Uttana vatarakta w.s.r. to Varicose Veins. |