| CTRI Number |
CTRI/2022/08/045114 [Registered on: 31/08/2022] Trial Registered Prospectively |
| Last Modified On: |
30/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Aragwadhadi Varti (Vaginal Suppository) on Abnormal Vaginal Discharge |
|
Scientific Title of Study
|
A Clinical Study of Aragwadhadi Varti in Abnormal Vaginal Discharge |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Meena |
| Designation |
P.G. Scholar |
| Affiliation |
University Post Graduate of Ayurved Studies and Research, Jodhpur, Rajasthan |
| Address |
P.G.Department of Prasuti Tantra evam Stri Roga, University Post Graduate Institute of Ayurved Studies and Research, Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8740956032 |
| Fax |
|
| Email |
meenaankita074@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Neelima |
| Designation |
HOD & Professor |
| Affiliation |
University Post Graduate of Ayurved Studies and Research, Jodhpur, Rajasthan |
| Address |
P.G.Department of Prasuti Tantra evam Stri Roga, University Post Graduate Institute of Ayurved Studies and Research, Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur,
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610350131 |
| Fax |
|
| Email |
aspneelima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Neelima |
| Designation |
Professor & HOD |
| Affiliation |
University Post Graduate of Ayurved Studies and Research, Jodhpur, Rajasthan |
| Address |
P.G.Department of Prasuti Tantra evam Stri Roga, University Post Graduate Institute of Ayurved Studies and Research, Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610350131 |
| Fax |
|
| Email |
aspneelima@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Post Graduate of Ayurved Studies and Research Jodhpur Rajasthan |
|
|
Primary Sponsor
|
| Name |
University Post Graduate of Ayurved Studies and Research Jodhpur Rajasthan |
| Address |
P.G.Department of Prasuti Tantra evam Stri Roga, University Post Graduate Institute of Ayurved Studies and Research, Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| 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 Ankita Meena |
University Post Graduate of Ayurved Studies and Research Jodhpur Rajasthan |
P.G.Department of Prasuti Tantra evam Stri Roga (OPD no.5), University Post Graduate Institute of Ayurved Studies and Research, Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN |
8740956032
meenaankita074@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Post Graduate Institute of Ayurved Studies and Research ,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni varti, योनि वरà¥à¤¤à¤¿ | (Procedure Reference: charaka chikitsa 30/ 70, Procedure details: patient kept in Lithotomy position than yoni prakshalana by sukhoshnajala & cleansing the vulva and vagina , varti anointed with sukhoshnajala then prepared varti should be introduced slowely into the vagina to posterior fornix, one Time in a Day)
(1) Medicine Name: Aragwadhadi varti, Reference: sushrut uttar 38/25, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 5(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Married women
Age group between 18 to menopause
The subjects who have the complaint of Vaginal Discharge along with any one of the complaint of pain or Vulval itching
A. Vaginal discharge
B. Vulval Itching
C. Pain
|
|
| ExclusionCriteria |
| Details |
Unmarried & married below the age of 18 year
Post menopausal women
Pregnant women
Known malignancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in cardinal and associated clinical features related to Abnormal Vaginal Discharge , pain , itching , vaginal ph
|
60 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in associated clinical features related to Abnormal Vaginal Discharge like weakness, burning micturation , local Tenderness
|
60 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/09/2022 |
| 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
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Abnormal vaginal discharge is a global problem and prevalent in developing countries. Now a day’s female possess a fear that it can cause dangerous disease like Carcinoma (CA). It may cause systemic and psychological disorder hence required treatment. In the cases of abnormal vaginal discharge Antibiotics are not that much effective. Due to its ignorance in early stage leads to dangerous condition (Great discomfort to woman and hamper their normal activities, sexual anxiety or failure conceive). Psychological upset -depression, anxiety, ill health, poor weight gain. Need has always been felt to develop certain Ayurvedic treatment modalities for the management of Abnormal vaginal discharge which could be safe, readily available, cost effective without any side effects. In comparison to the therapeutic procedures of different systems of medicine, Ayurveda has a potent approach towards the treatment of abnormal vaginal discharge by both internal and external medications. Previously used ayurvedic drug showed very encouraging results chosen drug for this study have same properties hence, it was planned to continue this study with the aim to evaluate the effect of Aragwadhadi Varti as an Aragwadha, Nimba, Karanja by combined administration of drug as varti can be established through Ayurveda. |