| CTRI Number |
CTRI/2020/12/030116 [Registered on: 30/12/2020] Trial Registered Prospectively |
| Last Modified On: |
04/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia
Preventive |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
KSHARA KARMA IN NADI VRANA |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF AGNIMANTHA PRATISARANEEYA KSHARA AND APAMARGA PRATISARANEEYA KSHARA IN THE MANAGEMENT OF NADI VRANA(PILONIDAL SINUS) |
| Trial Acronym |
KKNV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANANYA R |
| Designation |
POST GRADUATE SCHOLAR,DEPARTMENT OF SHALYA TANTRA |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL
B M ROAD
THANNERHALLA
HASSAN
THANNERUHALLA
B M ROAD
HASSAN
Hassan
KARNATAKA
573201
India |
| Phone |
8951757564 |
| Fax |
|
| Email |
ananyaranganth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRASANNA N RAO |
| Designation |
PRINCIPAL AND PROFESSOR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL
B M ROAD
THANNERHALLA
HASSAN
B M ROAD
THANNERHALLA
HASSAN-573201
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANANYA R |
| Designation |
POST GRADUATE SCHOLAR,DEPARTMENT OF SHALYA TANTRA |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL
B M ROAD
THANNERHALLA
HASSAN
KARNATAKA
573201
India |
| Phone |
8951757564 |
| Fax |
|
| Email |
ananyaranganth@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM INSTITUTION
SDM HOSPTAL,HASSAN |
|
|
Primary Sponsor
|
| Name |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
B M ROAD
THANNERHALLA
HASSAN-573201 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ANANYA |
OPD AND IPD OF DEPT OF SHALYA TANTRA |
SRI DHARMASTALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL B M ROAD THANNERHALLA
HASSAN-573201
Hassan
KARNATAKA |
8951757564
ananyaranganth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,SDM COLLEGE OF AYURVEDA,HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L050||Pilonidal cyst and sinus with abscess. Ayurveda Condition: NADIVRANAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AGNIMANTHA PRATISARANEEYA KSHARA |
DOSE -5GM
FREQUENCY-ONCE DURING SURGERY
DURATION-1 DAY,FOLLOW UP TILL 12 WEEKS
ROUTE OF ADMINISTRATION-OVER THE SINUS |
| Comparator Agent |
APAMARGA PRATISARANEEYA KSHARA |
DOSE -5GM
FREQUENCY-ONCE DURING SURGERY
DURATION-1 DAY,FOLLOW UP TILL 12 WEEKS
ROUTE OF ADMINISTRATION-OVER THE SINUS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
SUBJECTS HAVING SIGNS AND SYMPTOMS OF NADI VRANA(PILONIDAL SINUS)
SUBJECTS WITH WRITTEN SURGICAL CONSENT
SUBJECTS OF EITHER GENDER,RELIGION ,SOCIO ECONOMIC STATUS |
|
| ExclusionCriteria |
| Details |
UNCONTROLLED DIABETES(HbA1c>7)
KOCK,S DISEASE
OSTEOMYELITIS
HIV HBSAG
PREGNANCY
CARCINOMA
SINUS WITH MULTIPLE OPENING
SEVERE SYSTEMIC ILLNESS |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
COMPLETE WOUND HEALING
NON REOCCURANCE OF PILONIDAL SINUS |
BASELINE,4 WEEKS,8 WEEKS,12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NON RECCURANCE OF PILONIDAL SINUS |
2 MONTHS |
|
|
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)
|
30/12/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS AN OPEN LABEL TWO ARM NON RANDOMIZED COMPARATIVE STUDY.PATIENTS WILL BE SELECTED IN CONVIENIENT METHOD. THERE WILL BE TWO GROUPS TO BE COMPARED.ONE WILL BE MANAGED BY APAMARGA PRATISARANEEYA KSHARA(CONTROL GROUP) AND OTHER WITH AGNIMANTHA PRATISARANEEYA KSHARA(TRIAL GROUP) FOLLOWED BY DAILY DRESSING WITH JATHYADI TAILA FOR SEVEN DAYS AND A FOLLOW UP PERIOD OF 2 MONTHS. THE STUDY WILL BE CONDUCTED IN HOSPITAL ATTACHED TO AYURVEDA MEDICAL COLLEGE WITH LABORATORY FACILITIES OUTCOME IS ASSESSED BY COMPLETE HEALING OF WOUND ALONG WITH REDUCTION IN PREVIOUS SYMPTOMS AND NON RECCURANCE FOR A PERIOD OF 2 MONTHS. |