| CTRI Number |
CTRI/2026/02/104933 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Shatavari-Infused Gauze Dressing on Healing in Patients with Venous Leg Ulcers. |
|
Scientific Title of Study
|
A randomized open-label clinical study to compare the efficacy of Shatavari Vikeshika with Patoladi Vikeshika in the Management of Dushta Vrana with special reference to Venous Ulcer |
| 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 Rahul Gavade |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of PG Studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, Bengaluru
Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bangalore, Karnataka 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9922416187 |
| Fax |
|
| Email |
rahulgavade456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padma Bhat |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of PG Studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, Bengaluru
Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9900410580 |
| Fax |
|
| Email |
drpadmabhats@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Gavade |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of PG Studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, Bengaluru
Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9922416187 |
| Fax |
|
| Email |
rahulgavade456@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rahul Gavade |
| Address |
Department of PG Studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, Bengaluru
Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082 |
| 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 Rahul Gavade |
Sri Sri College of Ayurvedic Science and Research |
Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082
Bangalore
KARNATAKA |
9922416187
rahulgavade456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I830||Varicose veins of lower extremities with ulcer. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Patoladi Gana, Reference: Su/Su 38/34, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Patoladi Gana–
Patola,Chandana, Kuchandana,Murva,
Guduchi,Pata,Katurohini | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shatavari, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Shatavari, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects aged between 21-70 years irrespective of gender,religion,occupation,socio economic status and educational status.
2)Subjects fulfilling the diagnostic criteria of venous ulcer.
3)sunjects fulfilling the lakshana of pittaja dhusta vrana which is daha,shoola,rakta pitta vrana,chirasthitha,athi gandha.
4)subjects willing to give consents. |
|
| ExclusionCriteria |
| Details |
1)Subjects with Arterial ulcer, Malignant ulcer, and Tubercular ulcer.
2)Subjects diagnosed with HIV,HCV and HBsAg.
3)Subjects suffering from Severe Systemic Disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the efficacy of Shatavari Vikeshika with Patoladi Vikeshika in the management of Dushta Vrana w.s.r. to venous ulcer. |
0th ,7th , 14th ,21st and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To do the literature review on Vikeshika.
2)To do the literature review on Patoladi Vikeshika.
3)To do the literature review on Dushta Vrana and Venous ulcer.
4)To record potential side and adverse effects of Shatavari Vikeshika. |
21st and 28th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 STUDY
HAS BEEN TAKENUP TO EVALUATE THE EFFICACY OF SHATAVARI VIKESHIKA
IN THE MANAGEMENT OF DUSHTA VRANA WITH SPECIAL REFERENCE TO VENOUS ULCER
COMPARISION
WITH PATOLADI VIKESHIKA
RESEARCH
QUESTION :
Whether
Shatavari Vikeshika is effective in the management of Dushta Vrana w.s.r. to
Venous ulcer in comparison with Patoladi Vikeshika ?
NULL HYPOTHESIS –
[H0] : There is no significant difference between
the efficacy of Shatavari Vikeshika and Patoladi Vikeshika in the management of
Dushta Vrana w.s.r. to Venous ulcer.
ALTERNATIVE HYPOTHESIS –
[H1] - There is significant difference between the
efficacy of Shatavari Vikeshika and Patoladi Vikeshika in the management of
Dushta Vrana w.s.r. to Venous ulcer. |