| CTRI Number |
CTRI/2022/12/047900 [Registered on: 06/12/2022] Trial Registered Prospectively |
| Last Modified On: |
02/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study Of Raal churna (resin of shorea robusta) And Nagkeshara(Mesua ferrea Linn.) Churna In the treatment Of White vaginal Discharge(Leucorrhoea) in females. |
|
Scientific Title of Study
|
Pharmaco-Therapeutic Study Of Shala(Shorea robusta Gaertn.f)Niryasa And Nagkeshara(Mesua ferrea Linn.) Churna In Management Of Sweta Pradara - A Comparative Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aayushi Jain |
| Designation |
Post Graduation Scholar |
| Affiliation |
Government Dhanvantari Ayurvedic Medical College And Hospital Ujjain |
| Address |
OPD No 52 Department of Dravyaguna
Government Dhanvantari Ayurvedic Medical College And Hospital
Ujjain
Madhya Pradesh
456006
India
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
6267026922 |
| Fax |
|
| Email |
draayushijain03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiromani Mishra |
| Designation |
Reader of Department of Dravyaguna |
| Affiliation |
Government Dhanvantari Ayurvedic Medical College And Hospital Ujjain |
| Address |
2nd floor Department of Dravyaguna
Government Dhanvantari Ayurvedic Medical College And Hospital
Mangalnath Road Ujjain
Madhya Pradesh
456006
India
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9893158853 |
| Fax |
|
| Email |
shiromishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiromani Mishra |
| Designation |
Reader of Department of Dravyaguna |
| Affiliation |
Government Dhanvantari Ayurvedic Medical College And Hospital Ujjain |
| Address |
2nd floor Department of Dravyaguna
Government Dhanvantari Ayurvedic Medical College And Hospital
Mangalnath Road
Ujjain
Madhya Pradesh
456006
India
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9893158853 |
| Fax |
|
| Email |
shiromishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Autonomous Dhanvantari Ayurvedic College And Hospital Mangalnath Road
Ujjain
MP
456006 |
|
|
Primary Sponsor
|
| Name |
Government Dhanvantari Ayurvedic College And Hospital Ujjain |
| Address |
Mangalnath Road
Ujjain
Madhya Pradesh
456006 |
| Type of Sponsor |
Government 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 Shiromani Mishra |
Government Dhanvantari Ayurvedic College And Hospital Ujjain |
OPD no 52 Dravyaguna Department
Govt Dhanvantari Ayurveda Medical College and Hospital
Ujjain
456006
MP
Ujjain
MADHYA PRADESH |
9893158853
shiromishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt Dhanvantari Ayurveda College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N70-N77||Inflammatory diseases of female pelvic organs. 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: Shala Niryasa (Raal), Reference: Priya Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: lukewarm water ), Additional Information: churna given in the form of capsule | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagkeshara , Reference: vangsena stri rogadhikara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Buttermilk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1 Married Female Patients Of Age 18 to 55 Years
2 Patients Presenting With Complaints Of White Discharge Per Vginum
3 Patients Willing To Register And Sign The Consent Form
|
|
| ExclusionCriteria |
| Details |
1 Unmarried female
2 Patient having any type of malignancy
3 Patient having positive VDRL HIV HbsAg Tuberculosis Pelvic inflammatory diseases and STDs
4 Pregnant women and Lactating Mothers
5 Patient having any Chronic systemic Illness
6 Age below 18 year and above 55 year |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the Signs and Symptoms of white discharge including Amount of discharge at the time of baseline and at the end of the treatment (After 6 weeks) |
Change in the Signs and Symptoms of white discharge including Amount of discharge at the time of baseline and at the end of the treatment (After 6 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of change in the clinical parameters on 15th day |
30th and 45th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/12/2022 |
| 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
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is randomized interventional a Pharmaco-therapeutic Study Of Shala (Shorea robusta Gaertn.f) Niryasa and Nagkeshara (Mesua Ferrea Linn.) Churna in Management Of Sweta Pradara- A Comparative Study Total 60 Patients will be enrolled in the present study. Selected Patients will be divided into two groups on the basis of computer generated randomization. Group A 30 Patients will be treated with Shala Niryasa Churna 2 gms along with lukewarm water orally before meals TDS for 6 weeks Group B 30 Patients will be treated with Nagkeshara Churna 3 gms along with Takra orally before meals BD for 6 weeks Follow up will be taken on 15th day then 30 th day and lastly on 45th day |