| CTRI Number |
CTRI/2025/05/086893 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical and antimicrobial study to evaluate the effect of Kush Moola Churna and Nyagrodh Twak Kashaya in the management of Shweta Pradara w.s.r. to Leucorrhea |
|
Scientific Title of Study
|
A clinical and antimicrobial study to evaluate the effect of Kush Moola Churna and Nyagrodh Twak Kashaya in the management of Shweta Pradara w.s.r. to Leucorrhea |
| 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 Akhilesh kumar srivastava |
| Designation |
Professor |
| Affiliation |
RGGPG ayurvedic college and hospital paprola |
| Address |
PG department of Rog nidan ,RGGPG college and hospital paprola baijnath kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
916230118318 |
| Fax |
|
| Email |
drakhilesh.srivastava66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh kumar srivastava |
| Designation |
Professor |
| Affiliation |
RGGPG ayurvedic college and hospital paprola |
| Address |
PG department of Rog nidan ,RGGPG college and hospital paprola baijnath kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
916230118318 |
| Fax |
|
| Email |
drakhilesh.srivastava66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh kumar srivastava |
| Designation |
Professor |
| Affiliation |
RGGPG ayurvedic college and hospital paprola |
| Address |
PG department of Rog nidan ,RGGPG college and hospital paprola baijnath kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
916230118318 |
| Fax |
|
| Email |
drakhilesh.srivastava66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola,
Kangra, H.P., pincode - 176115, india |
|
|
Primary Sponsor
|
| Name |
R G G P G Ayurvedic College and Hospital |
| Address |
R G G P G Ayurvedic College and Hospital Paprola Kangra (HP) 176115 |
| 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 Akhilesh Kumar Srivastava |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
room no. 104 ,Rajiv
Gandhi Govt Post
Graduate Ayurvedic
College and Hospital,
Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
06230118318
drakhilesh.srivastava66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (human) Rajiv Gandhi government Post graduate Ayurvedic college and hospital paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
LEUCORRHEA |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kush moola, Reference: vrindmadhav, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: - tandulodak), Additional Information: - | | 2 | Intervention Arm | Procedure | - | prakShAlana-karma, प्रक्षालन-कर्म | (Procedure Reference: charak chikitsa , Procedure details: patients of this group will be given Kush Moola Churna with Tandulodak for 3 months with Nyagrodh Twak Kashaya Prakshalan and Pichu - for local application for 7 days for 3 consecutive cycles after clearance of menses.)
(1) Medicine Name: Nyagrodh Twak Kwatha, Reference: bhavprakash, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
patients willing for trial and ready to give written consent
married females in the age group between 20-45 yrs
patients having clinical signs and symptoms of pathological leucorrhea
abstinence from sexual intercourse during study period of minnimum of 2-4 weeks |
|
| ExclusionCriteria |
| Details |
patients not willing for the trial
unmarried females
pregnant females
patients having unexplained vaginal bleeding
history of use of antibiotics or local vaginal formulation taken within last 15 days
patients suffering from uterine or cervical tumour, fibromyoma,polyp,prolapse or ovarian cyst
patients having any systemic disorder like severe anaemia,DM,tuberculosis
patients having endocervical smear positive for gonococci or positive VDRLor HIV test
patients having abnormal pap smear with intraepithelial lesion or invasive cancer
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in sign and symptoms of shweta pradara with Kush Moola Churna and Nyagrodh Twak Kashaya oral and local application respectively
kin patient |
Relief in sign and symptoms of shweta pradara with Kush Moola Churna and Nyagrodh Twak Kashaya oral and local application respectively
kin patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study cytological changes in Pap Smear.
To study vaginal wet mount smear .
To check the anti-microbial effect of Kush (Desmostachya bipinnata (Linn.) and Nyagrodh (Ficus Religiosa ( (Linn.) on culture.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
02/06/2025 |
| 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="0"
Months="3"
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
|
I would like to publish my research work after completion of the trial as soon as possible. Patients
will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital,Paprola. 20 patients will be registered and assessed to evaluate the effect of kush moola churna and nyagrodh twak kashaya in management of leucorrhea . |