| CTRI Number |
CTRI/2025/02/080728 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate the Effect of Panchavalkaladi TailaYoni Pichu Dharan in the Management of Acharana Yonivyapad |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial to Evaluate the Effect of Panchavalkaladi TailaYoni Pichu Dharan in the Management of Acharana Yonivyapad with Special Reference to Pruritus Vulvae |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSayali Bharatkumar Vengurlekar |
| Designation |
PG Scholar |
| Affiliation |
R.A.Podar Medical (Ayu) college,worli |
| Address |
Gynaec Department first floor Podar Hospital ,Worli
Mumbai -400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7769849489 |
| Fax |
|
| Email |
sayalivengurlekar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManoj Vitthal Gaikwad |
| Designation |
HOD PROFESSOR in Obstetrics and Gynaecology Department |
| Affiliation |
R.A.Podar Medical Ayu College Worli |
| Address |
Gynaec and Obstetrics Department first floor Podar Hospital Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9822752816 |
| Fax |
|
| Email |
drmanojvgaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrManoj Vitthal Gaikwad |
| Designation |
HOD PROFESSOR in Obstetrics and Gynaecology Department |
| Affiliation |
R.A.Podar Medical Ayu College Worli |
| Address |
Gynaec and Obstetrics Department first floor Podar Hospital Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9822752816 |
| Fax |
|
| Email |
drmanojvgaikwad@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 8 M.A.Podar Hospital Worli Mumbai 400018
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Sayali Bharatkumar Vengurlekar |
| Address |
First floor Gynaec and Obstetrics Department Podar Hospital Worli Mumbai 400018
Maharashtra India |
| Type of Sponsor |
Other [] |
|
|
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 Sayali Bharatkumar Vengurlekar |
M.A.Podar Hospital Worli |
Department of Gynaecology and Obstetrics first floor Podar Hospital Worli Mumbai 400018
Mumbai
MAHARASHTRA |
7769849489
sayalivengurlekar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC R A.Podar medical College Worli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: Charak chiktsa , Procedure details: Once a day for 7 days )
(1) Medicine Name: Nimb tail , Reference: Bhav Prakash , Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: Charak chiktsa , Procedure details: Once a day for 7 days )
(1) Medicine Name: Panchavalkayadi tail , Reference: Charak chiktsa , Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1) Female having per vaginal itiching.
2) Age between 18-70 yrs married female patient.
3) Female who are willing to participate |
|
| ExclusionCriteria |
| Details |
) Pregnant women
2) Local gynaecological causes like ovarian cyst, prolapse, fibromyoma, polyps.
3) Neoplasm (Cervical or uterine malignancy)
4) patients with bleeding disorders
5) Those suffering from congenital anomalies of genital tract
6) Pelvic inflammatory diseases
7) Patients with sexually transmitted diseases
8) Abnormal uterine bleeding
9) Patients with severe hepatic or cardiac or renal disorders
10) Those having leukaemia or platelet deficiency disorders
11) Females in their puerperium period
12) Patient with severe anaemia
13) HIV HbsAg VDRL,HPV positive patients
14) Patients with DM,HTN |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significantly reduction in Pruritus |
8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significantly reduction in Pruritus by using Panchavalkayadi tail yoni pichu than Nimb tail yoni pichu |
8 days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
20/02/2025 |
| 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 Yet Recruiting |
| 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
|
Objective - To evaluate whether the Panchavalkaladi Taila Yoni Pichu Dharan in Acharana YoniVyapad (yoni kandu) with special reference to pruritus vulva Group A - Panchavalkayadi tail Group B - Nimb tail Appropriate Sampling Technique: Simple randomised sampling method by computerised random technique will be done for 76 female patients of age group 18 to 70 years.
The subjects will be randomised in two study groups i.e., Group A and B. The time and date of recruitment shall also be recorded in the enrolment log
Follow up: 8 th day.
Assessment Criteria: The study will be strictly based on assessment of subjective parameter by the grading them.
The data obtained will be analyzed statistically.
Observation and Results: Observation and results will be drawn according to assessment criteria.
Discussion: The observed phenomena will be discussed.
Conclusion: Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased
Summary: The research study will be summarized in brief.
Ethical Consideration: The study will be conducted in accordance with ethical guidelines and inform consent from participant. |