| CTRI Number |
CTRI/2025/07/090596 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
leech therapy in non-healing ulcer with analysis of leech saliva for its microbial load |
|
Scientific Title of Study
|
Evaluate the efficacy of Hirudotherapy in the management of non-healing ulcer with pre and post analysis of Leech saliva for its microbial load- A Randomized control 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 Pawan Lalsangi |
| Designation |
Associate professor |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya, Dept of Shalya tantra, Belagavi - 590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
8748035055 |
| Fax |
|
| Email |
ambiciouspawan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Lalsangi |
| Designation |
Associate professor |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya, Dept of Shalya tantra, Belagavi - 590010, Karnataka, India
KARNATAKA
590010
India |
| Phone |
8748035055 |
| Fax |
|
| Email |
ambiciouspawan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Shindhe |
| Designation |
Professor |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya, Dept of Shalya tantra, Belagavi - 590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Hospital & Research center, Dept of Shaklyatantra OPD no.4, Ankali 591213, Tq- Chikodi, Dist - Belagavi, karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Pawan Lalsangi |
| Address |
Dr N A Magadum Ayurvedic Hospital & Research center, Dept of Shaklyatantra OPD no.4, Ankali 591213, Tq- Chikodi, Dist - Belagavi, karnataka, India |
| 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 Pawan Lalsangi |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
Dr N A Magadum Ayurvedic Hospital and Research center, Dept of Shalyatantra OPD no.4, Ankali - 591213 Tq- Chikodi, Dist - Belagavi, Karnataka, India
Belgaum
KARNATAKA |
8748035055
ambiciouspawan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.NAMAMC-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalokaawacharana | (Procedure Reference: sushrut samhita, Procedure details: Jaloukawacharana on baseline , 7th day, 15th day
)
(1) Medicine Name: Kaishore guggulu , Reference: Ch.Su.24/18 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 15 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kaishore guggulu , Reference: Ch.Su.24/18, Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -sukoshna jala), Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with normal CT, BT and Hb%.
Symptoms of chronic non-healing wound/ Dushtavrana (present for more than 4 weeks i.e. Dirghakalanubandi) with classical signs of Durgandha, vedhana, utsangi atipooyasrava, atigandha with Pooyasrava,
Subjects with either sex and age between 18yr to 70 years,
Yogya for jalokaavacharana according to classics,
Subject who submits a written informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients who have completed participation in any other clinical trial during the past six (06) months,
Subjects with K/C/O bleeding disorders,
Wound with excessive loss of tissue,
Ayogya for Jalokaawacharan including Sarvangashopha, Pandu, Udara, Shosha, Subjects with H/O HIV I&II, HBsAg infections, severe anemia, or any other chronic illness (Like Diabetes, Hypertension, etc),
Wound with other disorders e.g. Malignant ulcers, Syphilitic ulcers, Lepromatous ulcers, Tubercular ulcers, Severe Anemia, Burns.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hirudotherapy as add on treatment is effective in the management of Non-Healing Ulcer.
Reduction in the microbial load (Pre and post application) of leech Saliva in Hirudotherapy.
|
The frequency of Leech saliva will be collected before application, immediately after second vomitus and on 7th day.on this sample collect all data and compare .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/07/2025 |
| 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="11"
Days="0" |
|
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
|
The present study title “Evaluate
the efficacy of Hirudotherapy in the management of non-healing ulcer with pre
and post analysis of Leech saliva for its microbial load- A Randomized control
trial “ in the management of Dushta vrana will be conducted on 80 subjects with 40 in each group with mentioned objective and subjective parameters. one group will be treated with kaishora guggulu, aragwadadhi kashaya, jatyadi tail L/A, and other group with Jaloukawacharana with kaishora guggulu, aragwadadhi kashaya, jatyadi tail L/A. Assesment of leech saliva microbial load and patient will be done on 8, 16, 30th day. |