| CTRI Number |
CTRI/2025/01/079136 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Hijama bish shart (wet cupping) and compression stockings] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Wet cupping for varicose vein: efficacy and safety |
|
Scientific Title of Study
|
Efficacy of Hijama bish shart(wet cupping) in primary varicose vein (Dawali)- A randomized controlled clinical trial |
| 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 Budeppa |
| Designation |
PG Scholar Department of Ilaj bit Tadbeer |
| Affiliation |
National Institute of Unani Medicine, Bangalore |
| Address |
OPD No 28, National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
8147627855 |
| Fax |
|
| Email |
budeppatimmapur8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department Department of Ilaj bit Tadbeer |
| Affiliation |
National Institute of Unani Medicine, Bangalore |
| Address |
OPD No 28, National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department Department of Ilaj bit Tadbeer |
| Affiliation |
National Institute of Unani Medicine, Bangalore |
| Address |
OPD No 28, National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore 560091 Karnataka |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore 560091 Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Budeppa |
National Institute of Unani Medicine, Bangalore |
OPD 28 Department of Ilaj bit Tadbeer National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore 560091
Bangalore
KARNATAKA |
8147627855
budeppatimmapur8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) for Biomedical Research |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
compression stockings |
Control treatment: Compression stockings The elastic compression stocking exerting 20-30 mm Hg of pressure, will be worn daily for 21 days during the daytime (for at least 8 hours) from the ankle to below the knee and removed during the night. |
| Intervention |
Hijama bish shart (wet cupping) and compression stockings |
subjects in the test group will undergo 3 sittings of HijÄma bish Shará¹ at regular intervals of 7 days (0 day, 7th day and 14th day) and the last assessment for efficacy done on the 21st day. Duration of protocol treatment is 21 days. The wet cupping will be done by following standard operative procedure. One medium-sized (5.2 cm) and one small-sized cup (3 cm) will be applied over the calf region at least 5 cm away from the maximum tortuosity of the most prominent varicose vein.
If both calves have varicosities, 2 cups will be applied on each limb. Approximately 10-15 tiny (2mm depth, 2mm length) superficial scarifications will be made at the cupped area and approximately 20 ml of blood will be drawn in medium and 10 ml in small cup and discarded as per NABH guidelines. The values of VCSS will be averaged if varicosities are present in both legs. The vitals of the patients will be recorded before and after the procedure. Compression stockings will be worn by all patients as mentioned in the control group for 21 days.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient clinically diagnosed case of primary varicose vein
2. willing to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
1.patients having grade 2 hypertension
2.patients of secondary varicose vein
3.pregnant and lactating women
4.patients who fail to follow up
5.patients having diabetus mellitus and other systemic illness eg cancer liver ,kidney, cardiac and pulmonary diseases
6.patients with haemoglobin less than 9.5gm/dl
7.patients having bleeding diathesis,HIV infection, hepatits B and C infection
8. patients of deep venous thrombosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VCSS Score (Revised venous clinical severity score) |
At Baseline, 7th day, 14th day, 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
20/02/2025 |
| 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
|
Title of study- Efficacy of Hijama bish shart (wet cupping) in primary varicose vein (Dawali)- A randomized controlled clinical trial
study design-single centre, two armed, parallel groups assessor blinded randomized controlled clinical trial
Intervention- subjects in the test group will undergo 3 sittings of HijÄma bish Shará¹ at regular intervals of 7 days (0 day, 7th day and 14th day) and the last assessment for efficacy done on the 21st day. The wet cupping will be done by following standard operative procedure. One medium-sized (5.2 cm) and one small-sized cup (3 cm) will be applied over the calf region at least 5 cm away from the maximum tortuosity of the most prominent varicose vein. If both calves have varicosities, 2 cups will be applied on each limb. Approximately 10-15 tiny (2mm depth, 2mm length) superficial scarifications will be made at the cupped area and approximately 20 ml of blood will be drawn in medium and 10 ml in small cup and discarded as per NABH guidelines. The values of VCSS will be averaged if varicosities are present in both legs. The vitals of the patients will be recorded before and after the procedure. Compression stockings will be worn by all patients as mentioned in the control group for 21 days.
control group- Compression stockings The elastic compression stocking exerting 20-30 mm Hg of pressure, will be worn daily for 21 days during the daytime (for at least 8 hours) from the ankle to below the knee and removed during the night.
Primary outcome measure- VCSS Score ( Revised venous clinical severity score)
sample size- 36
site of study- National Institute of Unani Medicine, Bangalore |