| CTRI Number |
CTRI/2022/10/046815 [Registered on: 26/10/2022] Trial Registered Prospectively |
| Last Modified On: |
26/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy Of Amalaki Ghanvati and Plaksha Yonivriti in Leucorrhoea |
|
Scientific Title of Study
|
A Clinical Study Of Amalaki Ghanvati and Plaksha Yonivriti in the management of Shwetaprader(Excessive 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 Meeta Jhala |
| Designation |
PhD Scholar |
| Affiliation |
University Post Graduate Institute Of Ayurved Study & Research DSRRAU Jodhpur RAJASTHAN |
| Address |
PG Department of Prasuti Tantra Evam Striroga
University Post Graduate Institute Of Ayurved Study & Research DSRRAU Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8107415431 |
| Fax |
|
| Email |
meetajiten6978@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu Dutt Sharma |
| Designation |
Assistant Professor |
| Affiliation |
University Post Graduate Institute Of Ayurved Study & Research DSRRAU Jodhpur RAJASTHA |
| Address |
PG Department of Shalya Tantra
University Post Graduate Institute Of Ayurved Study & Research DSRRAU Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7742042974 |
| Fax |
|
| Email |
ayurvishnu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu Dutt Sharma |
| Designation |
Assistant Professor |
| Affiliation |
University Post Graduate Institute Of Ayurved Study & Research DSRRAU Jodhpur RAJASTHA |
| Address |
PG Department of Shalya Tantra
University Post Graduate Institute Of Ayurved Study & Research DSRRAU Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7742042974 |
| Fax |
|
| Email |
ayurvishnu@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Post Graduate Institute of Ayurved Study and Research Jodhpur Rajasthan |
|
|
Primary Sponsor
|
| Name |
UPGIASR RAU JODHPUR RAJASTHAN |
| Address |
University Post Graduate Institute of Ayurved Study and Research DSRRAU JODHPUR RAJASTHAN |
| 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 Meeta Jhala |
UPGIAS&R DSRRAU KARWAR JODHPUR |
OPD Prasuti and Striroga Department room no.5 University Post Graduate Institute of Ayurved Study and Research, Dr. Sarvepalli Radhakrishanan Rajasthan Ayurved University Karwar Jodhpur
Jodhpur
RAJASTHAN |
8107415431
meetajiten6978@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:N738||Other specified female pelvic inflammatory diseases. Ayurveda Condition: Shwetapradar, (2) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: Shwetapradar, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Plaksha Yonivarti, Reference: Ch./Chi -30, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki Ghanvati, Reference: Ch./Chi.-30, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Married women patient having sign and symptoms of Shwetapradar |
|
| ExclusionCriteria |
| Details |
Unmarried women, patients suffering from VDRL, HIV, HTN and DM.
Patients with any diagnosed uterine adnexal pathology and malignancy.
Patients on hormonal therapy.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Amalaki Ghanvati and Plaksh Yonivarti in Shwetapradar |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effecacy of the drug in excessive vaginal discharges due to different- different micro-organism through high vaginal swab culture.
To identify adverse effect if any. |
21 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
27/10/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Shwetapradar or excessive vaginal discharge is evident from persistent vulvar moistness or staining of the under garments or need to wear pad. It may be physiological and pathological. Shwetapradar is responsible for psychological upset, depression, anxiety, ill health and poor weight gain in affected women. we need to find out proper management with no side effects and long lasting relief for excessive vaginal discharge. With this backgrounds, an effort is made to evaluate the efficacy of Amalaki ghanvati and Plaksh yonivarti in series of patient suffering from sahwetapradar. |