| CTRI Number |
CTRI/2023/05/052447 [Registered on: 10/05/2023] Trial Registered Prospectively |
| Last Modified On: |
09/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of nagakesar churna with butter milk in white vaginal discharge |
|
Scientific Title of Study
|
Clinical study on shweta pradara w.s.r candida albicans with nagakesar churna and takra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krutika Mishra |
| Designation |
PG Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya |
| Address |
OPD Number 3 Department Of Prasuti Tantra Evum Stri Roga
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya
Khurja
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9536796855 |
| Fax |
|
| Email |
kmkrutika1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramoda Kumar Majhi |
| Designation |
Professor |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya |
| Address |
OPD Number 3 Department Of Prasuti Tantra Evum Stri Roga
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya
Khurja
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7608066632 |
| Fax |
|
| Email |
professormajhi2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramoda Kumar Majhi |
| Designation |
Professor |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya |
| Address |
OPD Number 3 Department Of Prasuti Tantra Evum Stri Roga
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya
Khurja
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7608066632 |
| Fax |
|
| Email |
professormajhi2016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya and Hospital Khurja bulandshahr UP 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Krutika Mishra |
| Address |
OPD NO 3 Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya
Khurja |
| Type of Sponsor |
Other [Self] |
|
|
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 Krutika Mishra |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja |
OPD Number 3 Department of Prasuti Tantra Evum Stri Roga
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja
Bulandshahar
UTTAR PRADESH |
9536796855
kmkrutika1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya khurja Bulandshahr UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N763||Subacute and chronic vulvitis. 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: Nagakesar churna, Reference: Bhavaprakash chikitsa 69/11 soma Roga Adhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients having thick curdy white vaginal discharge
2 Patients having signs and symptoms same as candida albicans infection
3 Age group- 12 - 60 yrs
4 Patients diagnosed with Shweta Pradara
5 Patients diagnosed with uncomplicated Candida albicans
6 Patients diagnosed with recurrent and severe Candida albicans |
|
| ExclusionCriteria |
| Details |
1 Presence of infective organisms other than Candida albicans
2 Positive VDRL, HIV (STDs)
3 Oral contraceptive pills and contraceptive devices
4 Positive pap smear
5 Non-albicans candidiasis
6 Women with uncontrolled diabetes, debilitation, or immunosuppression
7 Uterine tumour or any other growth. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from candida albicans infection |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved immune system |
8 weeks |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/05/2023 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Shweta Pradara, commonly characterized as white vaginal discharge, is not a disease but a symptom of so many diseases. It is the white vaginal discharge with intense vulvovaginal pruritus. Therefore I have correlated Shweta Pradara with Candida Albicans infection or Candidiasis. so under this trial, Nagakesar churna will be given to 40 patients with Takra Anupaan as mentioned in Bhava Prakash chikitsa and Yoga Ratnakar in Soma Roga Adhikar. The trial drug will be given for 15 days with takra as anupana including the menstrual cycle. Follow Up with all the patients will be done every 15 days for 2 cycles. After the trial, the followup will be done after 1 month. |