| CTRI Number |
CTRI/2025/07/090726 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Understanding the effect of Nimba Kshara on wound healing after fistulectomy operation |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Nimba Kshara Pratisaran in the management of Post Operative Partial Fistulectomy Hypergranulated Wound |
| 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 Snehal Shivaji Kayande |
| Designation |
M.S. Scholar, Shalyatantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
OPD No. 16 of Shalyatantra Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya , Kanchanwadi, Aurangabad- 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7498553916 |
| Fax |
|
| Email |
snehalkayande623@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gadve Babasaheb Nana |
| Designation |
Professor and HOD of Shalyatantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad |
| Address |
OPD No. 16 of Shalyatantra Departmant, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad-431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822682898 |
| Fax |
|
| Email |
drgadvekayakalp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Shivaji Kayande |
| Designation |
M.S. Scholar Shalyatantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
OPD No. 16 of Shalyatantra Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad-431001
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7498553916 |
| Fax |
|
| Email |
snehalkayande623@gmail.com |
|
|
Source of Monetary or Material Support
|
| Departmant of Dravyaguna, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad, Maharashtra, India-431001 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad |
| Address |
Shalayatantra Department, Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad-431001 |
| 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 Snehal Shivaji Kayande |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
OPD No.16 of Shalyatantra Department Aurangabad, Maharashtra
Aurangabad
MAHARASHTRA |
7498553916
snehalkayande623@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved Mahavidyalaya and Rugnalaya Chhatrapati Sambhajinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K918||Other intraoperative and postprocedural complications and disorders of digestive system. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Sushrut samhita Dr. Anantram sharma by edition 2021, Chikitsa sthan adhyay 1, shlok no 86 and Sushrut samhita Ayurved Tantvansdipika Ambikadutt shastri ,Sutrasthan adhyay 11, shlok no 20. , Procedure details: Patient of hypergranulated wound after confirming the adequate investigation according to the inclusion criteria will be taken. The patient will be taken to the minor OT table. Wound will be cleaned with iodine solution. Kshar will be taken by using spatula according to size of wound. Kshar will be apply to hypergranulated area. After kshar application will be wait and observe for drying of kshar. Then kshar will be wiped with cotton and vrana will be washed with pure lime juice. Dressing will be done. )
(1) Medicine Name: Apamarga kshar , Reference: Sushrut samhita Ayurved Tantvansdipika Dr. Ambikadutt shastri, Sutrasthan adhyay 11, shlok no 12. , Route: Topical, Dosage Form: Kshara, Dose: 3(mg), Frequency: od, Duration: 28 Days | | 2 | Intervention Arm | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Sushrut samhita Dr Anantram sharma by edition 2021, Chikitsa sthan, adhyay 1, shlok no. 86 and Sushrut samhita Ayurved Tantvansdipika, Dr. Ambikadutt shastri , Sutrasthan adhyay 11, shlok no 20, Procedure details: Patient of hypergranulated wound after confirming the adequate investigation according to the inclusion criteria will be taken. The patient will be taken to the minor OT table. Wound will be cleaned with iodine solution. Kshar will be taken by using the spatula according to size of wound. Kshar will be apply to hypergranulated area. Aftykshar application will be wait and observe for drying of kshar. Then kshar will be wiped with cotton and vrana will be washed with pure lime juice. Dressing will be done. )
(1) Medicine Name: Nimba kshar, Reference: Sushrut samhita Ayurved Tantvansdipika Dr. Ambikadutt shastri ,Sutrasthan adhyay 11, shlok no. 12, Route: Topical, Dosage Form: Kshara, Dose: 3(mg), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed Patients having classical signs of hypergranulation in post operative partial fistulectomy wound , selection will be irrespective of sex, religion, and socioeconomic status, Age between 16-70 years. Wound size upto length of 4cm into 1 cm. |
|
| ExclusionCriteria |
| Details |
Patients with malignant ulcers.
Patients below age 16 and above 70 years.
Gangrenous wond.
Bleeding disorders.
Patients suffering from DM, HTN |
|
|
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 reduce signs and symptoms of hypergranulation i.e. Pain, Itching, Size of Wound, Margin, Height of granulation tissue till 28 days |
Baseline, 7th day, 14th day, 21st day, 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the size of wound. |
Baseline, 7th day, 14th day, 21st day, 28th day |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
11/07/2025 |
| 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="6"
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
|
Hypergranulation is excessive granulation that rises above the wound surface. In post operative partial fistulectomy procedure, Hypergranulation is seen near the external opening of fistula.
Pratisarneeya kshara is used in the wound with symptoms like indurations, itching, and have raised hypertrophied granulation tissue.
Nimba kshara pratisaran is having Tridosh nashana, chedana, bhedana, lekhana and ropana properties which is useful for wound healing.
A Study will be conducted on 92 diagnosed patients having classical signs and symptoms of Hypergranulation in post operative partial fistulectomy wound.
Written informed consent will be taken.
Inital assessment on 1st day, then randomization will be done.
Group allocation with Group A and
Follow up on 7th, 14th, 21st, 28th day.
Observations and result will be noted.
Statistical analysis
Discussion and conclusion
Summary. |