| CTRI Number |
CTRI/2024/05/067835 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Advantage of Local application of Rohini Taila and Thumari Taila in the management of sirajanya vrana(venous ulcer). |
|
Scientific Title of Study
|
Efficacy of local application of Rohini Taila and Thumari Taila in the management of Sirajanya Vrana (Venous Ulcer) – An open labelled 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 |
Poonam Choudhari |
| Designation |
PG Scholar |
| Affiliation |
Institute of teaching and research in Ayurveda |
| Address |
Department of Shalya Tantra Institute of teaching and research in Ayurveda Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9929288408 |
| Fax |
|
| Email |
poonamchoudhary2323@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pashmina B Joshi |
| Designation |
Reader |
| Affiliation |
Institute of teaching and research in Ayurveda Jamnagar. |
| Address |
Department of Shalya Tantra Institute of teaching and research in Ayurveda Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9427226504 |
| Fax |
|
| Email |
PBJ@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pashmina B Joshi |
| Designation |
Reader |
| Affiliation |
Institute of teaching and research in Ayurveda Jamnagar. |
| Address |
Department of Shalya Tantra Institute of teaching and research in Ayurveda Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9427226504 |
| Fax |
|
| Email |
PBJ@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of teaching and research in Ayurveda Jamnagar. |
|
|
Primary Sponsor
|
| Name |
Institute of teaching and research in Ayurveda Jamnagar |
| Address |
Institute of teaching and research in Ayurveda Jamnagar361008. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poonam Choudhari |
Institute of teaching and research in Ayurveda Jamnagar. |
Shalya Tantra OPD -01 Institute of teaching and research in Ayurveda, Jamnagar.
Jamnagar
GUJARAT |
9929288408
poonamchoudhary2323@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of teaching and research in Ayurveda Jamnagar. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I830||Varicose veins of lower extremities with ulcer. Ayurveda Condition: VRANAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | local application of Thumari taila | (Procedure Reference: Susruta samhita, chikitsa sthana, chapter 1, Procedure details: Approximately 5ml of Thumari taila will be applied over the ulcer once daily for 30 days under asceptic precautions)
(1) Medicine Name: Thumari (securinega leucopyrus), Reference: other than classical, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 30 Days | | 2 | Intervention Arm | Procedure | - | local application of Rohini taila | (Procedure Reference: Susruta samhita, chikitsa sthana, chapter 1, Procedure details: approximately 5ml of Rohini taila will be applied over the ulcer under aseptic precautions once daily for 30 days )
(1) Medicine Name: Rohini (Soymida febrifuga), Reference: Susruta samhita, sutra sthana, chapter 38, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 30 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. The patient presented with Sirajanya Vrana (Venous Ulcer) as 2 or more clinical features of diagnostic criteria of venous ulcer & diagnosed cases of Sirajanya Vrana (Venous Leg Ulcer/Ulcers).
2. Patient of Sirajanya Vrana (Venous Ulcer), age group of 18 - 70 years, irrespective of gender, caste, religion and socioeconomic status.
3. Patient with/without HTN (BP less than 140/90mm/Hg) and DM (RBS less than150 mg/dl) with medication. |
|
| ExclusionCriteria |
| Details |
1. Patients having DVT (Deep Vein Thrombosis), embolism, bleeding disorders, arterial occlusion disease and other infective skin disorders.
2. Known case of cardiac diseases, malignancy, tubercular ulcers & known case of immune- suppressive disease.
3. Patient with/without HTN (BP greater than 140/90mm/Hg) and DM (RBS greater than 150 mg/dl) with medication.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
•Healing of Sirajanya Vrana (Venous Ulcer).
•Reduce in pain, odor of discharge and itching ,improvement in skin colour surrounding the wound.
|
30 day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absence of recurrence in the follow period |
Day 45 and day 60 |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
29/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
Over a 30-day clinical study, the efficacy of Rohini Taila and Thumari Taila was evaluated in the management of Sirajanya Vrana (Venous Leg Ulcer). Both formulations possess Ropana (healing), Shodhana (cleansing), anti-inflammatory, and antibacterial properties, which promote granulation tissue formation, epithelialization, collagen synthesis, and wound contraction, as supported by Ayurvedic and modern scientific principles. Kanchanar Guggulu was administered as an adjuvant to enhance venous circulation and systemic healing.Demographic observations revealed a higher incidence of Sirajanya Vrana among elderly males with sedentary lifestyles and lower socioeconomic backgrounds. Clinically, most ulcers were chronic or recurrent, presenting with pain, itching, exudation, and occasional burning sensations. Both treatment groups showed a marked reduction in pain, burning, itching, exudates, microbial load, and wound size.Although complete remission was not achieved in all cases, the majority of patients exhibited moderate to remarkable improvement. The study concludes that Rohini Taila and Thumari Taila are effective in promoting wound healing, alleviating symptoms, and enhancing patient comfort. These findings advocate the integration of traditional Ayurvedic approaches with contemporary wound-care concepts in the management of chronic venous ulcers.
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