| CTRI Number |
CTRI/2020/06/026150 [Registered on: 25/06/2020] Trial Registered Prospectively |
| Last Modified On: |
25/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Guggulu-shigru kshar sutra in fistula in ano |
|
Scientific Title of Study
|
A CLINICAL STUDY OF GUGGULU-SHIGRU KSHAR SUTRA IN BHAGANDARA (Low level Fistula) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Pankaj Kumar Sharma |
| Designation |
Prof |
| Affiliation |
Gurukul campus UAU |
| Address |
OPD 7 Gurukul campus UAU Haridwar Uttarakhand
Shalya tantra department Gurukul campus UAU Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9927067792 |
| Fax |
|
| Email |
drpankajsharma21@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Pankaj Kumar Sharma |
| Designation |
Prof |
| Affiliation |
Gurukul campus UAU |
| Address |
OPD 7 Gurukul campus UAU Haridwar Uttarakhand
Shalya tantra department Gurukul campus UAU Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9927067792 |
| Fax |
|
| Email |
drpankajsharma21@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Pankaj Kumar Sharma |
| Designation |
Prof |
| Affiliation |
Gurukul campus UAU |
| Address |
OPD 7 Gurukul campus UAU Haridwar Uttarakhand
Shalya tantra department Gurukul campus UAU Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9927067792 |
| Fax |
|
| Email |
drpankajsharma21@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Gurukul campus UAU haridwar |
|
|
Primary Sponsor
|
| Name |
Gurukul campus UAU Haridwar |
| Address |
Gurukul campus UAU Haridwar Uttrakhand |
| Type of Sponsor |
Government 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 Shivam Shukla |
OPD No. 7 Shalya tantra department, gurukul campus haridwar |
OPD No. 7 Shalya tantra department, gurukul campus Haridwar.
Hardwar
UTTARANCHAL |
8847333151
shivam.shukla03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K603||Anal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gugglu-Shigru kshar sutra |
This kshar sutra will be introduced into fistulous tract and will be changed every 7th day till the cut-through of the tract. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patient having signs and symptoms of bhagandra (low level fistula).
Fresh as well as recurrent case of bhagandra (low level fistula) will be taken for study.
|
|
| ExclusionCriteria |
| Details |
1. HIV I&II, HCV, HbSAg +VE patients
2. Secondary fistula due to Ca rectum, tuberculosis, ulcerative colitis and other. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO ESTABLISH KSHAR SUTRA TECHNIQUE IN FISTULA IN ANO
|
CUTTING OF FISTULOUS TRACK 0.5cm IN A WEEK - WEEK KSHAR
0.75cm IN A WEEK - MODERATE KSHAR
1cm IN A WEEK - STRONG KSHAR
1.5 cm IN A WEEK - VERY STRONG KSHAR
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO CONTROL REOCCURANCE RATE
DECREASES THE SUFFERINGS OF PATIENTS SUCH AS PAIN, BURNING SENSATION, ITCHING AND DISCHARGE |
1-Cured:91-100% relief in signs and symptoms 2-Markedly improvement:76-90% relief in signs and symptoms 3-Moderately improvement:51-75% relief in signs and symptoms 4-Mild improvement:26-50% relief in signs and symptoms 5-Unchanged/no improvement: less than or equal to 25% relief in signs and symptoms |
|
|
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)
|
25/06/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Fistula in ano is a troublesome disease. As most commonly used kshar sutra have multiple coating of snuhi ksheer and apamarg. But snuhi ksheer is irritant to skin thus causes pain to patient Also apamarga is not widely aviliable. Guggulu shigru kshar sutra is having repeated coating of guggulu which have anti-inflammatory and analgesic effect. thus this study is organized to lessen the sufferings of patient. 30 patients having sign and symptoms of bhagandra will be taken for study from OPD & IPD of Shalya tantra department of Gurukul campus. |