| CTRI Number |
CTRI/2022/07/043658 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess cutting and healing effect of apamargadi ksharasutra in patients with pilonidal sinus. |
|
Scientific Title of Study
|
Cutting and healing effect of apamargadi ksharasutra in pilonidal sinus. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mini M S |
| Designation |
PG student |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Mini M S,
PG Scholar,
Department of Salyatantra, Government Ayurveda College
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
8848213949 |
| Fax |
|
| Email |
minimohananm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subi N H |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Dr Subi N H, M.S (Ayu.)
Associate Professor,
Department of Salyatantra, Government Ayurveda College
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9495881390 |
| Fax |
|
| Email |
drsubironish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subi N H |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Dr Subi N H, M.S (Ayu.)
Associate Professor,
Department of Salyatantra, Government Ayurveda College
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9495881390 |
| Fax |
|
| Email |
drsubironish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College, Tripunithura |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College hospital Tripunithura |
| Address |
Government Ayurveda College
Tripunithura, Puthiyakav
PIN 682301
Ernakulam |
| Type of Sponsor |
Other [Government Ayurveda 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 |
| Mini M S |
Government Ayurveda College Hospital, Tripunithura |
Department of Salyatantra,
OP no - 4
Ernakulam
KERALA |
8848213949
minimohananm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L059||Pilonidal cyst and sinus without abscess. Ayurveda Condition: NADIVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Susrutha Samhitha, chiktsastana, 17, 29-32, Procedure details: Informed written consent/assent will be taken. Shaving and cleaning of the operative area will be done before procedure. The patient will be comfortably laid in the prone position. A malleable copper probe will be introduced into the external opening and it will be carefully introduced along the track. The probe will be brought out through the incised blind end. Apamargadi ksharasutra of suitable length will be passed through the eye of the probe and the probe will be pulled out to position the )
(1) Medicine Name: Apamargadi kshara, Reference: Gada nigraha, Route: Topical, Dosage Form: Kshara, Dose: 50(mg), Frequency: od, Duration: 70 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female participants in the age group of 15 years to 40 years will be enrolled.
2. Participants who have pilonidal sinus in sacrococcygeal diagnosed by clinical examination.
3. Participants with written informed consent/assent |
|
| ExclusionCriteria |
| Details |
1. Participants below 15 years of age and above 40 years of age.
2. Participants with uncontrolled Diabetes mellitus and Hypertension.
3. Known HIV/hepatitis B/VDRL positive participants will be excluded.
4. Known patients with tuberculosis.
5. Known patients with bleeding disorder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Unit Cutting Time of the ksharasutra measured
by the formula (Total no of days for cut through/Initial length of ksharasutra in
cm) and healing
effect of ksharasutra assessed by measuring length of resultant wound.
|
7th day, 14th day, 21st day, 28th day, 35th day,
42nd day, 49th day, 56th day, 63rd day, 70th
days for assessing Unit
Cutting Time. For assessing healing effect, 0th
day will also be considered (Day of application of
the ksharasutra)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of ksharasutra in discharge, itching and pain. |
0th day, 7th day, 14th day, 21st day, 28th day,
35th day, 42nd day, 49th day, 56th day, 63rd
day, 70th days. |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
04/07/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The trial will be conducted to assess the cutting and healing effect of apamargadi ksharasutra, prepared out of apamarga, palasha, kadalikanda, swarjika kshara and shankhanabhi bhasma [as per Gada nigraha by Shodala] in pilonidal sinus. The study will be conducted in participants who are clinically diagnosed with pilonidal sinus, attending the OP and IP, Department of Salyatantra, Government Ayurveda College Tripunithura, in the age group 15 to 40 years, who satisfy the inclusion and exclusion criteria. The study duration is till cut through of the pilonidal tract or till a maximum of 70 days. Primary outcomes are Unit Cutting Time and healing effect out of which the former is assessed by the formula - Total number of days for cut through/Initial length of the ksharasutra in cm and the latter is assessed by measuring length of resultant wound after ksharasutra cut through. Secondary outcomes include effect of this ksharasutra in itching, pain and discharge in the conditions, which are assessed by the grading prepared by Paul O’ Madson and Peter. Primary outcomes except Unit Cutting Time and healing effect are assessed on weekly from 0th day till 70th day and Unit Cutting Time and healing effect will be assessed on the basis of length of ksharasutra and length of resultant wound after succeeding changes from 7th day onwards till 70th day. Secondary outcomes will be assessed from 0th day (day of application of the ksharasutra) till 70th day. |