| CTRI Number |
CTRI/2024/06/068580 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two formulations that are Palashadi Gel and Palashadi Varti in patient of Pichhila Yoni Abnormal vaginal discharge |
|
Scientific Title of Study
|
Evaluate the efficacy of Palashadi Gel and Palashadi varti in management of Pichhila Yoni(Abnormal vaginal discharge)-An Open label Randomized control clinical trial. |
| 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 Charu Arya |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda,Gautampuri, Sarita Vihar New Delhi |
| Address |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi-110076
South
DELHI
110076
India |
| Phone |
9868118537 |
| Fax |
|
| Email |
aryacharu2211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Vinayak Gaikwad |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi |
| Address |
Department of PTSR All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
9270825656 |
| Fax |
|
| Email |
swativgaikwad369@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sujata Kadam |
| Designation |
HOD and Professor |
| Affiliation |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi |
| Address |
Department of PTSR All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
9890305370 |
| Fax |
|
| Email |
sujatadkadam@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Gautampuri,Sarita Vihar New Delhi-110076 INDIA |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Gautampuri Sarita Vihar New Delhi-110076 |
| 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 Charu Arya |
All India institute of Ayurveda |
Academic block,Department of Prasuti tantra evum stree roga ,fourth floor ,room number-405,Gautampuri Sarita Vihar New Delhi-110076
South
DELHI |
9868118537
aryacharu2211@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: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 | Drug | Classical | | (1) Medicine Name: Palashadi Gel, Reference: Charak Chikitsa, Route: Vaginal, Dosage Form: Kalka/ Paste , Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -The dose will be of 3 gm or quantum sufficient | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Palashadi Varti, Reference: Charak Chikitsa , Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -1 Varti will contain 3gm of drug |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Clinical cases of Pichhila Yoni like Srava,Kandu, vedna |
|
| ExclusionCriteria |
| Details |
1) Pregnant women
2) Systemic illness like Dm,CKD,
3) K/C/o Cervical and endometrial cancer
4) Immunocompromised |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Subjective Parameters which are
white discharge, itching PV, Pain, post coital bleeding,dyspareunia |
At baseline, 7th day and 14th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antimicrobial Property of Palashadi Gel by presence/absence of microbes (Fungus,Bacteria etc) |
7th & 14th Day |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="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
|
This is an open label randomized control clinical trial comparing the efficacy of Palashadi gel and Palashadi varti in management of Pichhila yoni ( abnormal vaginal discharge) in total 68 patients ( married females)divided in 2 groups equally of age 18 and above for the duration once daily for 7 days administered per vaginal Including conditions like srava,kandu,vedna etc., excluding pregnant females, systemic diseases like DM,CKD,k/c/o cervical and endometrial cancer and immuno-compromised.Study will be conducted at All India Institute of Ayurveda.Primary outcome of the study will be Improvement in subjective parameters and secondary outocme will be Antimicrobial property of Palashadi Gel .
|