| CTRI Number |
CTRI/2025/04/084217 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two drugs kinshuk gel and thrombophob gel in patients with thrombophlebitis |
|
Scientific Title of Study
|
Evaluation Of comparative efficacy of newly developed Kinshuk gel versus active control compound (Heparin Sodium plus Benzyl Nicotinate in the management of Thrombophlebitis (Sira Granthi Vikar) (RCT) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Nakum |
| Designation |
BAMS PG scholar |
| Affiliation |
Mahatma gandhi ayurved college salod wardha datta meghe higher education and research center |
| Address |
Room no 13 Department of Shalya tantra
Room no 13 Department of Shalya tantra
Wardha
MAHARASHTRA
442001
India |
| Phone |
09484888838 |
| Fax |
|
| Email |
mansinakum001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devyani Dasar |
| Designation |
MS Shalyatantra |
| Affiliation |
Mahatma gandhi ayurved college salod wardha datta meghe higher education and research center |
| Address |
Room no 13 Department of Shalya tantra
Room no 13 Department of Shalya tantra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503630392 |
| Fax |
|
| Email |
devyanidasar06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devyani Dasar |
| Designation |
MS Shalyatantra |
| Affiliation |
Mahatma gandhi ayurved college salod wardha datta meghe higher education and research center |
| Address |
Room no 13 Department of Shalya tantra
Room no 13 Department of Shalya tantra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503630392 |
| Fax |
|
| Email |
devyanidasar06@gmail.com |
|
|
Source of Monetary or Material Support
|
| patients in Mahatma Gandhi Ayurved College Hospital and Research Center , Salod (Hirapur),salod, Wardha, Maharashtra-442001, India |
|
|
Primary Sponsor
|
| Name |
Dr Mansi Nakum |
| Address |
Room no 13, Department of Shalya tantra, Mahatma Gandhi Ayurved College Hospital and Rsearch Centre, Salod, Wardha,Maharashtra- 442001, India |
| Type of Sponsor |
Other [dr. mansi nakum] |
|
|
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 Mansi Nakum |
Mahatma gandhi ayurved college hospital and research center salod wardha |
Room no 13, Department of Shalya Tantra, Salod, Wardha, 442001 Maharashtra, India
Wardha
MAHARASHTRA |
9484888838
mansinakum001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: SIRAJAGRANTHIH, (2) ICD-10 Condition:I808||Phlebitis and thrombophlebitis ofother sites. Ayurveda Condition: SIRAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: kinshuk gel, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | thrombophob gel | heparine sodium and benzyle nicotinate
topically in tds frequency for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient willing with written informed consent as per Helsinki declaration.
2) Age group of 17 to 70 years.
3) Patients with clinical features of thrombophlebitis (swelling , redness , pain , warmth)
4) Patients irrespective of gender, occupation and economic status.
|
|
| ExclusionCriteria |
| Details |
1) Phlebitis caused by Malignancy, Septicemia, deep vein thrombosis or with pus formation
2) Uncontrolled and insulin dependent Diabetes Mellitus, Uncontrolled Hypertension , Tuberculosis, Carcinoma Endocrine Disorders and Kidney or hepatic disorder.
3) Sites of thrombophlebitis – sensitive places like : genitals, eye lids, lips
Pregnant and lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kinshuk gel is as equally efficacious as Standard Compound in the management of Thrombophlebitis sira granthi vikar |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreases swelling pain tenderness |
Decreases swelling pain tenderness |
| Decrease pain swelling tenderness clot dissolve |
7days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="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
|
Thrombophlebitis is defined1
as formation of blood clot inside the vein resulting
inflammation of adjacent tissue of wall. it Also known as phlebothrombosis or venous
thrombosis.1
Pathophysiological causes include presence of a thrombus in the lumen of a superficial
vein, followed by Inflammatory reaction of its wall and adjacent tissue. It precedes
thrombophlebitis is initiated by triad of changes: endothelial damage, alteration in the
composition of blood and venous stasis. It represents as swelling, tenderness, redness etc.
there is bruises, blood clot under the skin also may be seen.
in 1856 Virchow identified three predisposing factors – slowing of blood stream, changes
in blood vessel wall, changes in blood itself. Also called as Virchow’s Triad Those who
are immobile after surgery, obese, having varicose veins etc. it happens by trauma to vein.
With various external injury or internal factors. Here the major cause of superficial
thrombophlebitis is by venous injury like intra venous catheter, intra venous injection etc.
there are 3 types of phlebitis mainly mechanical, chemical, infectious. Mechanical
thrombophlebitis occurs when peripheral IV catheter not secured properly leading tissue
damage. In Chemical phlebitis occur by irritants like drugs, infectious thrombophlebitis
produced when using contaminated catheter during Iv insertion. Among them there is
30% cases 2
involving IV cannula linked thrombophlebitis.
Thrombophlebitis migrates in which multiple thrombus appears in superficial vein and
although deeper can be involved. Some other factor like secondary infection, bacteremia
etc. in which circulating organism settle in intima of vein and produce phlebitis with
secondary thrombosis. Here the major cause ofsuperficial thrombophlebitis is by venous
injury like intra venous catheter, intra venous injection etc.
For superficial thrombophlebitis topical Heparin is used with Benzyle nicotinate topically
for 7 days duration. 2
In view of ayurveda thrombophlebitis can be corelate with siragat vikar, As siragranthi 3.
Sira granthi explained by Aacharya Sushrut in Nidan sthan as type of granthi. Which is
caused by vatadi dosha dushti, mamsa and asruk dushti. In samprapti bhedan vyayam aadi
nidan sevan cause vat dushti which cause sirapratan, sira sampidan, sira sankoch, sira
vishoshan and in results vrut & aashu sira granthi appears. Sira is updhatu of rakta dhatu.
Sira genesis done by essence part of rakta dhatu. In thrombophlebitis there is raktavaha
dushti and siragat vikar. In correlation blood clot may be shonit sanghat in sira. |