CTRI Number |
CTRI/2023/07/055139 [Registered on: 12/07/2023] Trial Registered Prospectively |
Last Modified On: |
10/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Managment of Karnini Yonivyapad (Cervical Erosion) through Ayurveda. |
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the efficacy of Palashadi Varti and Pippalyadi Varti in the management of Karnini Yonivyapad w.s.r. Cervical Erosion |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Jitesh Kumar Panda |
Designation |
Professor |
Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
Address |
Room No 112 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra HARYANA 136118 India |
Phone |
9896033056 |
Fax |
|
Email |
drjk67@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jitesh Kumar Panda |
Designation |
Professor |
Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
Address |
Room No 112 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra HARYANA 136118 India |
Phone |
9896033056 |
Fax |
|
Email |
drjk67@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Jitesh Kumar Panda |
Designation |
Professor |
Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
Address |
Room No 112 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra HARYANA 136118 India |
Phone |
9896033056 |
Fax |
|
Email |
drjk67@gmail.com |
|
Source of Monetary or Material Support
|
Shri Krishna Ayush University Kurukshetra Haryana 136118 |
|
Primary Sponsor
|
Name |
Shri Krishna Government Ayurvedic College and Hospital Kurukshetra |
Address |
OPD No.15,Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra |
Type of Sponsor |
Other [Government Ayurvedic 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 Deepika |
Shri Krishna Government Ayurvedic College and Hospital |
OPD No. 15 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra Kurukshetra HARYANA |
08607131358
deepikajangra08@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:N86||Erosion and ectropion of cervix uteri. Ayurveda Condition: KARNINI, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | vartiH, वरà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Bhaisjya Kalpana Chapter 5 Panchavidh Kashya kalpana, Procedure details: 1.Patient will be lying in lithotomy position. 2.Adhoudar Snehan and Swedan will be given before application of varti.
3.Under aseptic measures Pippalyadi Varti will be inserted in the Yoni.
4. After that Yoni Prakshalana with lukewarm water will be done.) (1) Medicine Name: Pippalyadi Varti , Reference: Charka Samhita Chikitsha Sathana Chapter 30/72, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 10(g), Frequency: od, Duration: 7 Days | 2 | Comparator Arm | Procedure | - | vartiH, वरà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Bhaisjya Kalpana Chapter 5 Panchavidh Kashya kalpana, Procedure details: 1.Patient will be lying in lithotomy position. 2.Adhoudar Snehan and Swedan will be given before application of varti. 3.Under aseptic measures Palashadi Varti will be inserted in the Yoni. 4. After that Yoni Prakshalana with lukewarm water will be done.) (1) Medicine Name: Palashadi Varti, Reference: Charka Samhita Chikitsha Sathana Chapter 30/122, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 10(g), Frequency: od, Duration: 7 Days |
|
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
1. Married women of reproductive age group (21-45) years of age.
2.Patients with symptoms related to Karnini Yonivyapad(white discharge P/V, Vulval itching and pain)
3.Per speculum examination – reddened area around the external os (Cervical Erosion)
4.Patients who are willing to go for relevant investigations.
|
|
ExclusionCriteria |
Details |
1.Patients with any diagnosed uterine organic pathology like Uterine Fibroid, Adenomyosis.
2.Patients with systemic diseases like hypertension, diabetes mellitus etc.
3.Patients with coagulopathy, anaemia, thyroid dysfunction etc.
4.Patients with malignancy or undiagnosed neoplasm.
5.Patients with pregnancy, history of recent delivery (during puerperal period) or abortion.
6.Patients with genital tuberculosis.
7.Patients suffering from sexually transmitted diseases.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Changes in subjective and objective parameters of Cervical Erosion |
30 Days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Yonigatasrava (Amount of white discharge per vaginum)
2.Yoni kandu(Vulval itching)
3.Udarashula(Lower abdominal pain)
4.Katishula (Lower backache)
5 Mutradaha (Burning micturition)
|
30 Days |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/08/2023 |
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="0" 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
|
About 85% women suffer from the cervical erosion i.e. benign condition of female genital tract during their lifetime. It is asymptomatic in initial stage but later on it progresses to show many symptoms like white discharge, itching vulva, dyspareunia etc. It adversely affects the physiological & psychological health of women & even interferes in their professional life. It may even lead to infertility. It can show malignant changes in chronic stage . Hence theoretically, treating cervical erosion may prove to be protective against the incidence of cervical cancer. Thus erosion would, by exposing this epithelium, aid an infective process. That’s why it is important to pay attention towards this troublesome disease and to detect these lesions early enough and treat them adequately if cancer of the cervix is to be warded off. Allopathic medicines such as antibiotics and pessaries gave relief for temporarily but patient again developed the same symptoms after cessation of treatment. Ayurveda offers different kind of treatment modality in the management of Karnini Yonivyapad like Yoni Dhavana/Prakshalana (vulval& perineal toileting), Pichu (tampon), Varti (wick), Lepa (paste), Dhoopana (fumigation), Yoni Purana (filling) and Uttara Basti. There is a need for an alternative, safe and cost effective remedy in ayurvedic system, as we know Palashadi Varti having Tridoshahara specially Kaphavatahara properties and Pippalyadi Varti having Teekshna, ushna properties and are also Kaphahara in nature so this research has been undertaken to compare the efficacy of defined drug in Karnini Yonivyapad. |