| CTRI Number |
CTRI/2025/02/080794 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on effect of Guduchi kashaya parisheka and oral ayurveda medicines in the treatment of Vatarakta (venous eczema). |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Guduchi (Tinospora cordifolia) kashaya parisheka with shamanoushadis in Vatarakta w.s.r to Venous eczema. |
| 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 Sinchana S R |
| Designation |
Post Graduate Scholar |
| Affiliation |
SDM College of Ayurveda Hospital and Research centre, Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre, Kuthpady, Udupi,
Department of Shalya tantra,
Shalya tantra General OPD,
OPD no 5
Udupi
KARNATAKA
574118
India |
| Phone |
9164356564 |
| Fax |
|
| Email |
srsinchana912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth K |
| Designation |
Associate professor |
| Affiliation |
SDM College of Ayurveda Hospital and Research centre, Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre, Kuthpady, Udupi,
Department of Shalya tantra,
Shalya tantra General OPD,
OPD no 5
Udupi
KARNATAKA
574118
India |
| Phone |
9448857560 |
| Fax |
|
| Email |
drp235@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sinchana S R |
| Designation |
Post Graduate Scholar |
| Affiliation |
SDM College of Ayurveda Hospital and Research centre, Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre, Kuthpady, Udupi,
Department of Shalya tantra,
Shalya tantra General OPD,
OPD no 5
Udupi
KARNATAKA
574118
India |
| Phone |
9164356564 |
| Fax |
|
| Email |
srsinchana912@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda Hospital and Research Centre, Kuthpady, Udupi,
Karnataka,
India,
574118 |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre, Kuthpady, Udupi, Karnataka, India, 574118 |
| Type of Sponsor |
Private medical college |
|
|
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 Sinchana S R |
IPD, SDM Ayurveda Hospital, Udupi |
SDM College of Ayurveda Hospital and Research Centre, Kuthpady, Udupi,
Department of Shalya tantra,
Shalya tantra General OPD,
OPD no 5
Udupi
KARNATAKA |
9164356564
srsinchana912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L308||Other specified dermatitis. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Shushrutha Samhita, Procedure details: Kashaya would be poured over affected skin from a height of 10cms for 15 mins daily)
(1) Medicine Name: Guduchi, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with signs and symptoms of Vatarakta w.s.r to venous eczema.
2.Patients aged 18-80 years.
|
|
| ExclusionCriteria |
| Details |
1.Patients presenting with acute DVT.
2.Uncontrolled Diabetes mellitus.
3.Immune-compromised patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain
2. Itching
3. Burning sensation
4. Edema
5. Discoloration
6. Discharge |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Skin lesion |
7 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Vatarakta, commonly correlated with venous eczema, is a condition characterized by skin discoloration, itching, swelling, and discomfort, often due to poor blood circulation in the legs. Ayurveda describes Vatarakta as a disorder caused by the imbalance of Vata and Rakta doshas. Guduchi (Tinospora cordifolia) is a well-known herb in Ayurveda with anti-inflammatory, immune-boosting, and skin-healing properties. It has been traditionally used in managing various skin disorders. This clinical trial aims to evaluate the effectiveness of Guduchi Kashaya Parisheka (therapeutic herbal decoction wash) along with Shamanoushadis (oral Ayurvedic medicines) in reducing the symptoms of Vatarakta (venous eczema), such as itching, swelling, and skin discoloration. The study seeks to provide scientific evidence for integrating Ayurvedic treatments in managing venous eczema and improving patients quality of life. |