| CTRI Number |
CTRI/2024/08/072704 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate the effect of Karanja Kshara and comparing it to Apamarga Kshara in Cervical erosion |
|
Scientific Title of Study
|
An open label randomized controlled clinical study to evaluate the effect of Karanja Kshara Lepa in KarniniYonivyapath visavis Cervical Erosion |
| 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 Spoorthi Sanjaya Bevur |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD No.9, Depatment of Prasuthi tantra evam Striroga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India
Mysore
KARNATAKA
570028
India |
| Phone |
9620790171 |
| Fax |
|
| Email |
bevur.spoorthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nanda K O |
| Designation |
Assistant Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD No.9, Department of Prasuthi tantra evam Striroga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India
Mysore
KARNATAKA
570028
India |
| Phone |
8970322532 |
| Fax |
|
| Email |
nandadeepak.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Spoorthi Sanjaya Bevur |
| Designation |
PostGraduate Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD No.9 , Dept of Prasuthi tantra evam Striroga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India
Mysore
KARNATAKA
570028
India |
| Phone |
9620790171 |
| Fax |
|
| Email |
bevur.spoorthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru, India 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Spoorthi Sanjaya Bevur |
| Address |
OPD No 9, Department of Prasuthi tantra evum Striroga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India 570028 |
| 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 Spoorthi Sanjaya Bevur |
JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru |
OPD No.9, Department of Prasuthi tantra evum Striroga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India 570028
Mysore
KARNATAKA |
9620790171
bevur.spoorthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, JSS Ayurveda Medical College, Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N86||Erosion and ectropion of cervix uteri. Ayurveda Condition: KARNINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: Ashtanga Sangraha Uttarasthana 39, Procedure details: The cervix will be cleaned with the help of sterile gauze piece. The Kshara will be applied over the affected area with the help of a cotton swab. It is allowed to be in place for period of 100 Matra Kala & till Pakwa Jambu Varna is observed. Then the Kshara will be removed & the area will be wiped with cotton swab dipped in Nimbu Swarasa.)
(1) Medicine Name: Apamarga Kshara, Reference: Sushruta Sutrasthana 12, Route: Vaginal, Dosage Form: Kshara, Dose: 1(g), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: Ashtanga Sangraha Uttarasthana 39, Procedure details: The cervix will be cleaned with the help of sterile gauze piece. The Kshara will be applied over the affected area with the help of a cotton swab. It is allowed to be in place for period of 100 Matra Kala & till Pakwa Jambu Varna is observed. Then the Kshara will be removed & the area will be wiped with cotton swab dipped in Nimbu Swarasa.)
(1) Medicine Name: Karanja Kshara, Reference: Sushruta Sutrasthana 12, Route: Vaginal, Dosage Form: Kshara, Dose: 1(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Married women, in the age group of 20 to 50 years
Subjects diagnosed with Cervical erosion |
|
| ExclusionCriteria |
| Details |
Subjects on oral contraceptive pills, and Intra Uterine Contraceptive Devices
Known Case of other cervical lesions like cervical polyp, cervical carcinoma and uterine prolapse
Sexually transmitted diseases
Known Case of coagulation disorder
Other systemic and metabolic disorders like Hypertension, Diabetes mellitus
Pregnant women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Size of the erosion
Normal appearance of Cervical Mucosa
|
15 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the quantity of discharge per vagina
Normal consistency of discharge per vagina
Absence of Pruritis vulvae |
15 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/08/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Cervical Erosion or Cervical Ectopy, is characterized by the replacement of the squamous
covering of the vaginal portion of the cervix with columnar epithelium, which remains
contiguous with the lining of the endocervix1
.
Cervial erosion or ectopy is the commonest lesion of the cervix. The prevelace rate of the
erosionwith the parity capturing up to 17%-50% of the population2.
The complications encountered by diathermy, cauterization, laser therapy, etc like local
operations on the cervix causes menstrual disturbances, reactionary haemorrhages, cervical
stenosis, sepsis, perforation of cervix, troublesome vaginal discharge and effect on subsequent
pregnancy and child birth.
The etimology and features of cervical erosion, it can be corelated to Karnini Yoni Vyapath. The
symptoms include Kapha Dushti Lakshana like Shwetha Pichhila Srava, Kandu in Yoni3
. And
the main treatment for Karnini Yoni Vyapath is mentioned as Sthanika Shodhana.
Going through the Kshara Gunas i.e.Ushna Virya, Tikshna Guna, Vrana Shotha Pachaka, Sroto
Shodhaka, Klinnata Shoshaka, Raktatisrava Stambhaka, Ropaka, Kathina Unnata Mamsadi
Lekhaka4
.
Comparing the line of treatment and the Kshara Gunas, it is observed that Kshara can be used in
the treatment of cervical erosion. Few studies have been done previously done with different
types of Kshaara in Karnini Yoni Vyapath. Karanja and Apamarga are the easily available drug ,
it is mentioned as Kshara Dravya’s according to Sushrutha and Vagbhata5,6 Karanja is
mentioned as Yonirogahara according to Dhavantrari Nighantu7
.
Yashtimadhu Taila has properties like Lekhana, Sodhana, Soshana, Stambhana, Sandhaniya,
Ropana and Varnya, Vedanahara
8
.
Keeping in view, the above-mentioned symptomatology and problems in treating them, there is
a need for an alternative, safe and cost-effective remedy in Ayurvedic system.
Hence the study “AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL STUDY
TO EVALUATE THE EFFECT OF KARANJA KSHARA LEPA IN KARNINI
YONIVYAPATH VIS-À-VIS CERVICAL EROSION†has been undertaken |