| CTRI Number |
CTRI/2024/11/076659 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of nimbagandhadi taila yoni pichu and nagakesharadi dhoopana yoga in vaginal infections |
|
Scientific Title of Study
|
A Randomised clinical study to evaluate the effect of Nimbagandhadi Taila yoni pichu and Nagakesharadi dhoopana yoga in vaginitis |
| 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 Sinhe Sharmistha Keshavrao |
| Designation |
PG scholar Department of Prasuti tantra and stree roga |
| Affiliation |
SDM college of ayurveda and research centre, kuthpady Udupi |
| Address |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, kuthpady,Udupi, Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9730869156 |
| Fax |
|
| Email |
sksinhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha KV |
| Designation |
BAMS MS(Ayu) PhD |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, kuthpady,Udupi, Karnataka |
| Address |
Department of Prasuti tantra and stree roga, OPD no 1, room no 300, Shri Dharmasthala Manjunatheshwara College of Ayurveda, kuthpady,Udupi, Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
08202520332 |
| Fax |
|
| Email |
mamath2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sinhe Sharmistha Keshavrao |
| Designation |
PG scholar Department of Prasuti tantra and stree roga |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, kuthpady,Udupi, Karnataka |
| Address |
Department of Prasuti tantra and stree roga, OPD no 1, room no 300,Shri Dharmasthala Manjunatheshwara College of Ayurveda, kuthpady,Udupi, Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9730869156 |
| Fax |
|
| Email |
sksinhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady,Udupi Karnataka India 574118 |
|
|
Primary Sponsor
|
| Name |
Shri Dharmasthala Manjunatheshwara College of Ayurveda |
| Address |
Shri Dharmasthala Manjunatheshwara college of ayurveda and research centre Kuthpady, Udupi, Karnataka India 574118 |
| Type of Sponsor |
Private medical college |
|
|
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 Sinhe Sharmistha Keshavrao |
Shri Dharmasthala Manjunatheshwara College of Ayurveda |
Prasuti tantra and stree roga department, Kuthpady, Udupi Karnataka India 574118
Udupi
KARNATAKA |
9730869156
sksinhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA, UDUPI INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE -HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Yoni | (Procedure Reference: Charak chikitsa 30th adhyaya yonivyapat chikitsa, Procedure details: Cotton ball dipped in luke warm oil and inserted in vagina )
(1) Medicine Name: Nimbagandha taila, Reference: Anukta yoga, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | dhUpana, धूपन | (Procedure Reference: Charak samhita chikitsasthana 30th chapter yonivyapad chikitsa adhyaya , Procedure details: The patient is told to evacuate the bladder.The pot which contained pre-heated coal till red hot is kept ready.The desired drugs in Churna form are added over it so as to produce dense fumes & kept under the chair with vent in the middle.The fumes reaches the external genitalia, passing through the vent. This is done till a desired time (5-10 min)
Followed by pichu of nimbagandha taila.)
(1) Medicine Name: Nagakesharadi dhupana yoga , Reference: Anukta yoga , Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 15(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients having cardinal symptoms of Bacterial vaginosis or Trichomoniasis vaginitis or vulvovaginal candidiasis Married women |
|
| ExclusionCriteria |
| Details |
Pregnant women Patient with cervicitis and cervical erosion Patient with senile vaginitis Patient with cervical polyps Patients with vulvar leukoplakia Women suffering from any systemic disease like uncontrolled diabetes TB STI HIV and HbSAg |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dyspareunia Dysuria Burning micturition Lower abdominal discomfort Offensive smell Itching Backache |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amount colour & consistency of vaginal discharge lower abdominal pain |
21 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/11/2024 |
| 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 study is a randamized open label study to evaluate the effect of nimbagandhadi taila yoni pichu and nagakesharadi dhoopana yoga in all types of vaginitis the intervention is for 7 days so before and after treatment with follow up period of 14 days the primary and secondary outcome will be recorded |