| CTRI Number |
CTRI/2026/03/105874 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the healing effect of Nimbadi taila externally along with internal medications in Chronic venous ulcer |
|
Scientific Title of Study
|
Effect of topical application of Nimbadi taila along with Guggulutikthaka kashayam and Kaisoraguggulu in Chronic venous ulcer : A Single arm 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 Deepa M S |
| Designation |
Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Shalyatantra
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9495437525 |
| Fax |
|
| Email |
drdeepams2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa M S |
| Designation |
Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Shalyatantra
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9495437525 |
| Fax |
|
| Email |
drdeepams2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surya P V |
| Designation |
PG- Scholar |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Shalyatantra
Government Ayurveda College
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7736133756 |
| Fax |
|
| Email |
suryaentrance@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College
Vanchiyoor
Thiruvananthapuram
695001
Kerala
India |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Thiruvananthapuram |
| Address |
Government Ayurveda College Thiruvananthapuram KERALA
695001 |
| Type of Sponsor |
Other [Government Ayurveda College Thiruvananthapuram] |
|
|
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 Surya P V |
Government Ayurveda College |
OP NO 3
Department of Shalyatantra
Government Ayurveda College Thiruvananthapuram KERALA 695001
Thiruvananthapuram
KERALA |
7736133756
suryaentrance@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Government Ayurveda College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L973||Non-pressure chronic ulcer of ankle. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimbadi tailam, Reference: keraleeyaoushada vinjanam, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kaisora guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guggulutiktakam kashayam, Reference: Ashtanga Hridayam Chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Participants with clinical signs and symptoms of chronic venous ulcer
2. Participants between the age of 40-60 years
3. Ulcer size not more than 10×15 cm.
b) EXCLUSION CRITERIA:-
1. Participants known to have uncontrolled Diabetes mellitus
2. Arterial ulcers |
|
| ExclusionCriteria |
| Details |
b) Exclusion criteria :-
1. Participants known to have uncontrolled Diabetes mellitus
2. Arterial ulcers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Size of Chronic venous ulcer
|
Assessment will be done on 0th 7th 14th 21th and 28th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Discharge and pain of Chronic venous ulcer |
Assessment will be done on 0th 7th 14th 21th and 28th day |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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)
|
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
|
This is an interventional pre and post study without a control group. Participants irrespective of gender, within the age group of 40-60 years attending OPD and IPD of Government Ayurveda College Hospital Thiruvananthapuram satisfying the inclusion criteria will be subjected to consecutive sampling and total of 28 participants will be selected for the study. In this study ulcer will be managed by cleaning and dressing with normal saline solution along with topical application of Nimbadi taila and internal administration of Guggulutikthaka kashayam and Kaisora guggulu. The duration is 28 days and assessment will be done on 0th 7th 14th 21st and 28th day based on subjective and objective criteria and the changes in parameters will be recorded. The result will be statistically analyzed based on the nature of the data using Paired t test Wilcoxon signed rank test Repeated measures ANOVA or Friedman test
|