| CTRI Number |
CTRI/2024/04/065462 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study the wound healing effect of ayurvedic medicine on wound of opening of uterus |
|
Scientific Title of Study
|
Randomized controlled trial to evaluate efficacy of panchavalkal kwath yonidhavan, panchavalkal taila yonipitchu and combination of both on garbhashay griva gat vrana with special reference to 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 Archana Subhash Jadhav |
| Designation |
PhD scholar |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalay Nashik |
| Address |
Pravara Medical Trust Ayurved Medical College and Saint Eknath Ayurved Hospital Shevgaon
Arogyashala Rugnalaya Ayurved Seva Sangh Ganeshwadi Panchavati Nashik-422003
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7775058616 |
| Fax |
|
| Email |
archu.jadhav88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Kanade |
| Designation |
Professor and Guide |
| Affiliation |
PMTs Ayurved College Shevgaon |
| Address |
Pravara Medical Trust Ayurved Medical College and Saint Eknath Ayurved Hospital Shevgaon
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9881413123 |
| Fax |
|
| Email |
prkanade73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash Kanade |
| Designation |
Professor and Guide |
| Affiliation |
PMTs Ayurved College Shevgaon |
| Address |
Pravara Medical Trust Ayurved Medical College and Saint Eknath Ayurved Hospital Shevgaon
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9881413123 |
| Fax |
|
| Email |
prkanade73@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMTs Ayurved College Shevgaon 414502 |
|
|
Primary Sponsor
|
| Name |
Dr Archana Subhash Jadhav |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi Panchavati Nashik 422003 |
| 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 Archana Subhash Jadhav |
Shree Sant Eknath Rugnalaya Shevgaon |
OPD no 113 Strirog OPD
Ahmadnagar
MAHARASHTRA |
7775058616
archu.jadhav88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PMTs Ayurved College Shevgaon Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N72||Inflammatory disease of cervix uteri. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: Charak Samhita, Procedure details: Cotton swab soaked with 10 ml Panchavalkala Taila applied in vagina (Cervix))
(1) Medicine Name: Panchavalkala Taila , Reference: Sushrut Samhita, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: Charak Samhita, Procedure details: Vaginal wash with 500 ml Panchavalkal quatha followed by Cotton swab soaked with 10 ml Panchavalkala Taila applied in vagina (Cervix) for 21 days))
(1) Medicine Name: Panchavalkal quatha, Panchavalkala Taila, Reference: Sushrut Samhita, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 21 Days | | 3 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Charak Samhita, Procedure details: Vaginal wash with 500 ml Panchavalkal quatha for 21 days)
(1) Medicine Name: Panchavalkal quatha, Reference: Sushruta Samhita, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married patients
Cervical errosion
Chronic cervicitis
Bacterial vaginosis |
|
| ExclusionCriteria |
| Details |
Venereal disease
Diabetes Malitus
Patient taking harmonal drug
Patient with IUCD and on oral contraceptive pills
Pregnancy
Suspected cases of CA cervix
Patient reactive with HIV,HbsAg,HIV
Cervical tumour, polyp, fibroid |
|
|
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 |
| Healing of cervical erosion |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in vaginal burning, lower backache, Vaginal itching, dysparunea |
21 days |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/04/2024 |
| 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
|
A randomised controlled trial will be conducted on 156 patients in 3 gropus ( 52 in each group) with diagnosed patient of cervical erosion , group A will be treated with panchavalkal kwath yonidhawan with one setting/day , Group B with panchavalkal tail pichu yoni dhavan once a day for 4 hour and Group C with combination of panchavalkal kwath yonidhavan and panchavalkal tail yoni pichu for 21 days , each patern will be adapted for 7 days after ceasation of menstrual flow for 3 consecutive cycle and efficacy will be evaluated |