| CTRI Number |
CTRI/2024/01/061066 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2023 |
| 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
|
Study Regarding local application of medicated oil in varicose veins |
|
Scientific Title of Study
|
A Randomized controlled clinical study to evaluate the efficacy of local application of Vatajatankuradi Tail in the treatment of Sirajgranthi with special reference to Varicose veins of lower limbs. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Rashi Ajay Bhavsar |
| Designation |
PG scholar |
| Affiliation |
Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik |
| Address |
OPD no.06 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
8850854774 |
| Fax |
|
| Email |
rashi.dec06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vinay Sonambekar |
| Designation |
professor and HOD Shalyatantra Department |
| Affiliation |
Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik |
| Address |
OPD no.06 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822624890 |
| Fax |
|
| Email |
sonambekar.chinmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Vinay Sonambekar |
| Designation |
professor and HOD Shalyatantra Department |
| Affiliation |
Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik |
| Address |
OPD no.06 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822624890 |
| Fax |
|
| Email |
sonambekar.chinmay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
|
|
Primary Sponsor
|
| Name |
VdRashi Ajay Bhavsar |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya Panchavati Nashik |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vd Rashi Ajay Bhavsar |
Arogyashala Rugnalaya |
OPD no 6 Shalyatantra OPD
Nashik
MAHARASHTRA |
8850854774
rashi.dec06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe ayurveda mahavidyalaya nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I868||Varicose veins of other specifiedsites. Ayurveda Condition: SIRAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vatajatankuradi Tail, Reference: Panchbhavtik chikitsa by Datarshastri, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Application of oil at lower limbs in opposite direction of hairgrowth for 5-10 mins | | 2 | Comparator Arm (Non Ayurveda) | | - | Calcium dobesilate ointment for local application | local application of 1-2gm calcium dobesilate ointment on lower limbs twice a day (in morning and at bed time) for 45 days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to participate in the study and those provide informed consent in written.
2.Patients with both Sex :Male and female
3.Patients diagnosed with Siraj granthi or varicose veins in lower extremity having clinical features -venous tortuosity, swelling ,pain and change in skin colour.
4.According to CEAP Classification patients till C5[skin changes with healed ulcers]and varicosity affecting Superficial veins will be included in this study.
|
|
| ExclusionCriteria |
| Details |
1.Patients those doesn’t give informed consent in written.
2.Patient with coagulopathy or bleeding diseases.
3.Known case of Varicosity associated with complications like deep vein thrombosis,calcification, equines deformity,venous ulcer.
4.According to CEAP Classification varicose ulcers, Congenital varicose veins and varicosity affecting deep and perforating veins will be excluded from this study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of varicose veins |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in Padashula, Padadaha, Padashotha, skin changes |
45 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
08/01/2024 |
| 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="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 is a condition affecting the lower limbs.In Addition of being a cosmetic issue,if not treated in a timely manner, it may result in serious complications like Eczema,Venous ulcers, Thromboplebitis ,Bleeding,etc. Varicosities can be treated surgically using a variety of techniques.Complications of Surgery are difficult to treat so apart from surgical interventions, safe treatment for Varicose veins (Siraj Granthi) should be done. Hence a Comprehensive holistic natural managementwhich aims at correcting the core pathology and preventing the prognosis is the need of the hour. Vatajatankuradi tail is patient friendly ,cost effective with no sideffects and gives symptomatic relierf preventing surgical consequences Total 80 cases will be selected by simple random sampling technique.Selected 80 cases will be divided in two groups i.e Grp A and Grp B. In Grp A Vatajatankuradi tail will be applied twice a for 6 weeks with followup after 15days for total 3 times. In Grp B Calcium Dobesilate ointment will be applied twice a day for 6 weeks with followup after 15 days for total 3 times. |