| CTRI Number |
CTRI/2026/02/103600 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Other (Specify) [Jalaukavacharana] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Evaluate Leech Therapy and Thrombophob Gel in Treating Thrombophlebitis (Inflammation of Veins with Blood Clots)” |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of jalaukavacharana (leech therapy) in thrombophlebitis (vranshotha) with thrombophob gel. |
| 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 NILESH ASHOK NANDALE |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda Hospital , Sangamner |
| Address |
OPD number 6 Shalyatantra department,Siddhakala ayurved mahavidyalay Sangamner ,Pimparne road ,Sangamner khurd,sangamner 422605
Ahemadnagar
MAHARASHTRA
OPD number 6 , Shalyatantra department,Siddhakala ayurved mahavidyalay Sangamner ,Pimparne road ,Sangamner khurd,sangamner 422605
Ahemadnagar,Maharashtra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7745088395 |
| Fax |
|
| Email |
nileshnandale09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naimish Kishor Saraf |
| Designation |
Head Of Department Of Shalyatantra |
| Affiliation |
Siddhakala Ayurveda Hospital , Sangamner |
| Address |
OPD number 6 Shalyatantra department,Siddhakala ayurved mahavidyalay Sangamner ,Pimparne road ,Sangamner khurd,sangamner 422605
Ahemadnagar
MAHARASHTRA
OPD number 6, Shalyatantra department, Siddhakala ayurved mahavidyalay Sangamner , Pimparne road , Sangamner khurd,sangamner 422605
Ahemadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NILESH ASHOK NANDALE |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda Hospital , Sangamner |
| Address |
OPD number 6 Shalyatantra department,Siddhakala ayurved mahavidyalay Sangamner ,Pimparne road ,Sangamner khurd,sangamner 422605
Ahemadnagar
MAHARASHTRA
OPD number 6, Shalyatantra department,Siddhakala ayurved mahavidyalay Sangamner , Pimparne road , Sangamner khurd,sangamner 422605
Ahemadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7745088395 |
| Fax |
|
| Email |
nileshnandale09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurveda Mahavidyalaya , Sangamner Khurd, Pimparne Road, Sangamner |
|
|
Primary Sponsor
|
| Name |
Dr NILESH ASHOK NANDALE |
| Address |
OPD number 6 Shalyatantra department,Siddhakala ayurved mahavidyalay Sangamner ,Pimparne road ,Sangamner khurd,sangamner 422605
Ahemadnagar
MAHARASHTRA |
| 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 Nilesh Ashok Nandale |
Siddhakala Ayurved mahavidyalaya and hospital,Pimparne road , sangamner |
OPD Number 6, Shalyatantra department, siddhakala Ayurved mahavidyalaya, pimparne road,sangamner
Ahmadnagar
MAHARASHTRA |
7745088395
nileshnandale09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Research and statistics committee of siddhakala Ayurved mahavidyalaya sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I809||Phlebitis and thrombophlebitis ofunspecified site. Ayurveda Condition: VRANASOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: Kaviraj AmbikaDatt Shastri , Sushrut Samhita Purvardh, Sutrasthan 13/5, Chaukhamba publication ; 2017, Procedure details: leech application done only 1 time & observation made 2nd 4th & 6th day.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Thrombophoeb gel. | local application BD for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age between 18-70 years.
2. Irrespective of Gender
3. Aagantuj Vranashotha with special focus on Acute Superficial thrombophlebitis.
4. Patients have developed thrombophlebitis due to IV Infusion and medication, trauma and infection of veins.
5. Thromboplebitis involving area less than 5 cm. |
|
| ExclusionCriteria |
| Details |
1.Patients receiving cancer chemotherapy drugs, steroid.
2.patients with known case of coagulopathies, polycythemia vera, buergers disease, mondors disease, DVT ,DM and arteriovenous disorders.
3.Patients with known case of HIV, immunosuppressive disorder,haemophilia, hepatitis B and other blood transmitting infection.
4.lactating mother ,pregnant mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical efficacy of Jalaukavcharan (leech therapy) and Thrombophob gel in the management of thrombophlebitis. such as reduction in pain, redness, swelling and palpable venous cord. |
0th Day (Baseline Assessesment) , 2nd day (Follow up), 4th Day(Follow Up ), 6th Day (Final Assessesment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the reduction in pain, swelling, and local tenderness in patients receiving Jalaukavcharan versus Thrombophob gel.
2.To evaluate the time taken for visible clinical improvement (such as reduction in limb circumference or erythema)
3.To assess any adverse effects or complications associated with Jalaukavcharan and Thrombophob gel.
4.To correlate the Ayurvedic signs and symptoms of Vranshotha with the clinical presentation of thrombophlebitis.
5.To study the changes happening in Jalauka (use for jalaukavacharan) over the time |
2nd Day (Baseline Assessesment) , 4th Day (Follow Up ), 6th Day (Final Assessesment) |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/03/2026 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This Study is Randomized Open Labelled Controlled Clinical Trial Comparing The Safety And Efficacy Of Jaluakavcharana For One Time And Controlled Local Application Of Thrombophoeb Gel For 7 Days BD In 60 Patients Divided in Two Groups And Observed The Visual Infusion Phlebitis Score And VAS Scale. |