| CTRI Number |
CTRI/2024/11/077097 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To See the Effect of Ayurvedic Procedure in the Management of Cervical Erosion |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF AGNIKARMA WITH PANCHDHATU SHALAKA AND CHANDRODAYA VARTI IN THE MANAGEMENT OF KARNINI YONIVYAPAD W.S.R. 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 Sunita Kumari |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute for Ayurved Studies and Research Umri road sector 08 kurukshetra Haryana 136118 |
| Address |
Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08 Kurukshetra Haryana 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
7009592208 |
| Fax |
|
| Email |
atinus661@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Professor and H.O.D , Department or Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute for Ayurved Studies and Research Umri road sector 08 kurukshetra Haryana 136118 |
| Address |
Room no 112 PG Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Kumari |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute for Ayurved Studies and Research Umri road sector 08 kurukshetra Haryana 136118 |
| Address |
Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08 Kurukshetra Haryana 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
7009592208 |
| Fax |
|
| Email |
atinus661@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studied and Research Umri road sector 08 Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Dr Sunita Kumari |
| Address |
Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118 |
| 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 Sunita Kumari |
Institute For Ayurved Studies and Research |
Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08 Kurukshetra Haryana 136118 Kurukshetra HARYANA
Kurukshetra
HARYANA |
7009592208
atinus661@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University 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 | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Samhita chapter 12, Procedure details: Purva karma
Patient will be explained about the Agnikarma procedure & written consent will be taken
Antiseptic dressing & draping done
Pradhan karma
Patient kept in lithotomy position with well flexed thighs & cervix is visualised with the help of speculum & then Agnikarma with Panchdhatu Shalaka will be done in Vinduvat clockwise direction on ectocervical eroded region
Single sitting after cessation of menses within 10 days
Paschat karma
After completion of Agnikarma Jatyadi tail pichu will be inserted till Amutra kaal
Advised Jatyadi tail pichu for seven days at bed time
)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Ashtanga Hridaya sutrasthan chapter 30, Procedure details: Purva Karma
Patient will be explained about the Agnikarma procedure and written consent will be taken
Pradhan Karma
Patient kept in lithotomy position with well flexed thighs and antiseptic cleaning and draping done
Cervix visualised with the help of speculum and then Agnikarma with Chandrodaya varti will be done in Vinduvat clockwise direction on ectocervical eroded region
Single sitting after cessation of menses within 10 days
Paschat karma
After completion of Agnikarma Jatyadi tail pichu will be inserted till amutra kaal
Advised Jatyadi tail pichu for seven days at bed time)
(1) Medicine Name: Chandrodaya Varti, Reference: Sharangdhar Samhita chapter 13 Netraprasadanvidhi Adhyay 13, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 15(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients with symptoms related to Karnini Yonivyapad.
2) Per speculum examination- bright red area surrounds the external os in the ectocervix with clearly demarcated outer edge.
3) Patients who are willing to go for relevant investigations.
4) Pap smear grading 1, 2
5) Cervical Erosion present after three months of delivery or three months after the stoppage of contraceptive pills.
6) Recurrence case of electro-cauterization after three months of treatment.
7) Suitable for Agnikarma. |
|
| ExclusionCriteria |
| Details |
1) Female patient of age less than 21 years and more than 45 years , Pt age more than 40 years with history of menopausal symptoms.
2) Patients with any diagnosed uterine pathology like Sub-mucosal pedunculated fibroid, Adenomyosis, Endometrial Polyp, Cervical Polyp etc.
3) Patients with coagulopathy
4) Patients with pregnancy, history of last delivery in duration of three months.
5) Pap smear grading 3,4,5
6) Diagnosed Systemic illness like genital T.B, Malignancy, Uncontrolled Hypertension, Diabetes mellitus etc.
7) Known case of sexually transmitted diseases like VDRL, HIV, Gonorrhoea etc.
8) Unsuitable for Agnikarma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Reduction in area of erosion with respect to that of cervix.
2) To improve the sign and symptoms associated with Karnini Yonivyapad.
|
Follow up on 7th day, 15th day, 25th day, 35th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in other associated clinical features related to Karnini Yonivyapad.
|
Follow up on 7th day, 15th day, 25th day, 35th day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
23/12/2024 |
| 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="6"
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 is one of the commonest gynaecological conditions seen in routine clinical practice in which the squamous epithelium of the ectocervix is replaced by columnar epithelium, which is continuous with the endocervix. It is asymptomatic in initial stage but in later stage, it progresses to show symptoms like white discharge, itching, contact bleeding, dyspareunia etc. Cervical erosion is a benign condition but if left untreated may predispose to cervical malignancy. Hence, early detection and treatment are crucial in managing this condition. The clear description of Cervical Erosion is not mentioned in Ayurveda classics but can be correlated with “Karnini Yonivyapad†“Garbhashaya Grivamukhgata Vrana†due to its clinical symptoms, etiopathogenesis and managementapproaches. Considering the features of cervical erosion, it can be stated that it is usually Nija /Agantuja, Kapha-Pittaja, Twaka- Mansaja type of Karnikaakara Granthi which occurs at Mukha of Garbhashaya. Cauterization, Cryosurgery, Diathermy and Laser therapy are the most common therapies used in modern science for treating which have their own side effects like bleeding per vagina, perforation of cervix, sepsis, menstrual disturbance, and secondary infertility. So, safe and cost-effective alternative treatment modalities are desirable which treats the condition in a holistic approach and prevent further development and recurrence. So present study is planned to evaluate the effect of Agnikarma with Panchdhatu Shalaka and Chandrodaya Varti locally. |