| CTRI Number |
CTRI/2026/01/102118 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of regimenal therapy in primary varicose vein |
|
Scientific Title of Study
|
Efficacy 0f fasd venesection and tila in dawali primary varicose vein a randomised controlled clinical trail |
| 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 Misba Usmani |
| Designation |
2 year PG scholar |
| Affiliation |
National institute of unani medicine |
| Address |
National Institute OF Unani Medicine, kottigepalya, Magadi Main road, Bangalore, KARNATAKA 560091 India
National Institute OF Unani Medicine, kottigepalya, Magadi Main road, Bangalore, KARNATAKA 560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
7030363253 |
| Fax |
|
| Email |
misbau456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Azeez |
| Designation |
Associate professor, Department of Ilaj bit Tadbeer |
| Affiliation |
National institute of unani medicine |
| Address |
National Institute OF Unani Medicine, kottigepalya, Magadi Main road.
National Institute OF Unani Medicine, kottigepalya, Magadi Main road.karnataka 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9072310021 |
| Fax |
|
| Email |
aafaris@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Azeez |
| Designation |
Associate professor, Department of Ilaj bit Tadbeer |
| Affiliation |
National institute of unani medicine |
| Address |
National Institute OF Unani Medicine, kottigepalya, Magadi Main road.
National Institute OF Unani Medicine, kottigepalya, Magadi Main road.karnataka 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9072310021 |
| Fax |
|
| Email |
aafaris@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr misba usmani |
| Address |
New girls hostel, national institute of unani medicine,kottigepalya, main magadi road,bangaluru 560091 |
| 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 |
| Dr Misba Usmani |
National institute of unani medicine |
NIUM,Dept of ilaj bit tadbeer National Institute OF Unani Medicine, kottigepalya, Magadi Main road, Bangalore, KARNATAKA 560091 India
Bangalore
KARNATAKA |
07030363253
misbau456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CAOMMUNICATION OF DECISION OF THE INSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I839||Asymptomatic varicose veins of lower extremities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
compression stokings |
The elastic compression stocking exerting 20 to 30 mm Hg of pressure, will be worn daily for 14 days during the daytime for at least 8 hours from the ankle up to the knee and removed at evening. |
| Intervention |
Fasd and Tila aaplication |
Patients will undergo venesection on the affected veins after full aseptic precautions and vital monitoring. after that the Tila will be applied over the engorged veins for a period of 6 hours daily. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients clinically diagnosed with primary varicose veins
Varicosity Mild to Moderate on venous clinical severity score
Patients between 30 to 60 years of Age
Either gender
Willing to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
Patients having grade II hypertension
Pregnant and lactating women
Patients who fail to follow up
Patients having uncontrolled Diabetes mellitus and other Systemic illness
Patients with Hb less than 9.5
Patients having bleeding diathesis, HIV infection, hepatitis B and C infection
Patients of deep venous thrombosis
Patients having varicose ulcers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Venous Clinical Severity Score (VCSS) |
0,7th ,14th,21st days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF -12 for quality of life. |
0,7th,,14th,21st days |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
07/02/2026 |
| 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 Yet Recruiting |
| 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
|
Diagnosed cases of primary varicose vein fulfilling the inclusion criteria will be randomly selected after obtaining written informed consent. Participants will be randomly allocated into two groups, with 24 patients in each group. The test group will be treated with fasd and local application of tila daily for 14 days, while the control group will be treated with compression stockings for 14 days. Patients will be assessed for primary and secondary outcome measures at baseline and after completion of the treatment period. The significance of differences between the two groups will be analyzed using appropriate statistical tests. |