| CTRI Number |
CTRI/2025/02/081080 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Clinical Study on the Therapeutic Efficacy of Ksharkarma and Agnikarma in Cervical Ectopy with Reference to Karnini Yonivyapad |
|
Scientific Title of Study
|
A Comparative Clinical Study on the Therapeutic Effect of Ksharkarma and Agnikarma in Cervical ectopy with special reference to Karnini Yonivyapad |
| 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 Umak Prachi Diliprao |
| Designation |
MS Scholar |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh
Room no 64 NAGARJUNA girls hostel IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7066238110 |
| Fax |
|
| Email |
pdu.prachi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Deepa Mishra |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science BHU Varanasi UP
Manduadeh near Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9650453095 |
| Fax |
|
| Email |
deepa1971mishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Deepa Mishra |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science BHU Varanasi UP
Manduadeh near Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9650453095 |
| Fax |
|
| Email |
deepa1971mishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu
University Varanasi Uttar pradesh 221005 |
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda Institute of Medical Sciences BHU |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda IMS BHU
Varanasi Uttarpradesh 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Umak Prachi Diliprao |
Sir Sunderlal Hospital BHU |
OPD No 24 Prasuti
Tantra OPD
Department of Prasuti
Tantra Faculty of
Ayurveda IMS BHU
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
7066238110
pdu.prachi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute of Medical Sciences Institutional Ethicas Committee Varanasi 221005 |
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: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Sushrut Sutrasthana 11, Procedure details: Under all aseptic conditions Cuscos speculum will be placed in vagina & intravaginal area will be cleaned with distilled water & dried by gauze piece.The Apamarga kshar will be taken and applied on entire eroded area with the help of cotton bud. Kshar will be kept in contact with eroded area for 100 matra kala.Then the cervical area will be washed with nimbu swarasa and dried by gauze piece.The yashtimadhu ghrita soaked pichu will be kept in contact with cervix.Cuscos speculum will be removed & patient is asked to keep the yoni pichu intravaginally till she feels the urge of urination or for 3 hours.
)
(1) Medicine Name: Apamarga, Reference: Bhavprakash Nighantu Guduchyadi varga 188, Route: Vaginal, Dosage Form: Kshara, Dose: 2(mg), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut Sutrasthana 12, Procedure details: Under all aseptic conditions Cuscos speculum will be placed in vagina & intravaginal area will be cleaned with distilled water & dried by gauze piece.The shalaka will be heated till the required temperature is attained. Bindu type agnikarma will be done in clockwise direction from ectocervix to endocervix in circular manner covering the whole eroded area.The yashtimadhu ghrita soaked pichu will be kept in contact with cervix.Cuscos speculum will be removed & patient is asked to keep the yoni pichu intravaginally till she feels the urge of urination or for 3 hours.)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married women aged 25to 40 years having cervical ectopy on per speculum examination with complaints like discharges per vaginum, contact bleeding or cervix bleeds on touch. |
|
| ExclusionCriteria |
| Details |
•Unmarried Women.
•Pregnant women, Post delivery less than and equal to 3 months, Post abortal period less than and equal to 15 days.
•Patient who is on hormonal pills.
•Women with uncontrolled DM.
•Patients having CIN ,Carcinoma of Cervix, Acute/active genital infections, Uterine prolapse grade III and IV
•Patient is on chemotherapy / radio therapy for any malignant condition of any organ.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the following parameters:
Area of extent of ectopy
Discharges per vaginum
Bleeding during per speculum examination
Associated symptoms pruritis vulvae,backache |
3 follow ups
(First Follow up on day 7 of main procedure, with 7 days of pichu application.
2nd and 3rd follow up at weekly interval, without medication)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced discharges per vaginum backache,alleviated symptoms and improved quality of life among study participants |
3 follow ups
(First Follow up on day 7 of main procedure, with 7 days of pichu application.
2nd and 3rd follow up at weekly interval, without medication |
|
|
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="5" |
|
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 ectopy or ectropion is a condition where the
squamous epithelium of the ectocervix is replaced by columnar epithelium, which
is continuous with the endocervix. Based on sign and symptoms it maybe
co-related with Karnini yonivyapad. According to Acharya Charaka due to Akala
pravahana i. e straining during labor in absence of labor pains causes
vitiation of Vata. This vitiated Vata mixes
with Shleshma and Rakta produces Karnika in yoni. According to Acharya Sushrut Shleshma and Rakta causes Karnini in yoni which
is called as Karnini yonivyapad. The symptoms observed are kandu (itching), picchila(sticky) Apamarga has Tikta rasa which
is Shodhana, Lekhana, Kledashoshana.Kshar has the ksharan (to
mobilize and remove the deformed body tissue) property.Kshar also
has tridoshaghna, chedana, lekhana properties. All these
properties results in destruction of overgrown columnar epithelium In Agnikarma the diseased tissue is
treated by inflicting burns on the tissue surface directly. The heat transferred increases the blood circulation
to the affected site thereby increasing the cellular activity and
metabolism.Thus promoting epithelization. Yashtimadhu the main
content has glycyrrhic acid ammonium salt which increases the
epithelization.
|