| CTRI Number |
CTRI/2025/05/086583 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Rohitaka Moola Kalka and Amalaki beeja kalka in the management of Shweta Pradara (Leucorrhoea) |
|
Scientific Title of Study
|
Comparative Clinical Study To Evaluate The Efficacy Of Rohitaka Moola Kalka & Amalaki Beeja Kalka In The Management Of Shweta Pradara w s.r. To Leucorrhoea |
| 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 Ayushi Baranwal |
| Designation |
MS PG Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja |
| Address |
Room no 25,26 Department of Prasutitantra evum stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9535541671 |
| Fax |
|
| Email |
ayushibaranwal12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama Khatavkar |
| Designation |
MD Ayurveda HOD Department of Prasutitantra evum stree Roga |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya |
| Address |
Room no 25,26 Department of Prasutitantra evum stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8755569692 |
| Fax |
|
| Email |
rama.khatavkar212@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rama Khatavkar |
| Designation |
MD Ayurveda HOD Department of Prasutitantra evum stree Roga |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya |
| Address |
Room no 25,26 Department of Prasutitantra evum stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
UTTAR PRADESH
203131
India |
| Phone |
8755569692 |
| Fax |
|
| Email |
rama.khatavkar212@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Ayushi Baranwal |
| Address |
Room no 25, 26 Department of Prasutitantra evum stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
| 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 Ayushi Baranwal |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
Room no 25,26 Department of Prasutitantra evum stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja
Bulandshahar
UTTAR PRADESH |
9535541671
ayushibaranwal12@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 Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki beeja, Reference: Yoga Ratnakar chapter 69 soma roga shloka no 11 , Route: Oral, Dosage Form: Kalka/ Paste , Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -madhu sharkara), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rohitaka, Reference: Charaka chikitsa sthana chapter no 30 shloka no 116, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women in the age group of 18-45 years
Patients complaining of white discharge per vaginum as a cardinal or associated symptom
Patients willing for trial and ready to give written consent
|
|
| ExclusionCriteria |
| Details |
Patients suffering from STD’s
Any other systemic disorder like Diabetes Mellitus
Patients having any other gynecological problems like prolapse, fibroid, etc
Pregnant women with profuse white discharge
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in amount of vaginal discharge |
3 months
The trial drug will be given for 3 months with anupana and follow up will be done after cessation of medicine in 4 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in Itching Lower backache and tenderness Per vagina |
After analyzing all the parameters the result will
be assessed on the basis of symptomatic relief
and improvement.
Partially improvement after 3 days- patient get
30 percent relief from sign and symptoms
Improvement after 1 month Patient get 40-50
percent relief from sign and symptoms
Improvement after 2 month patient get 60-80 percent relief from sign and symptoms
Cured after 3 month pateint get 80-100 percent
relief from sign and symptoms. |
|
|
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 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="10"
Days="10" |
|
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
|
The condition characterized with excessive secretion. Shweta pradara is not a disease but a symptom of various underlying health conditions. However, depending on the etiopathogenesis Shweta Pradara occurs due to vitiation of kapha which gets vitiated due to its own vitiating factor which further influences rasa dhatu along with other causative factors.There are several drugs for Shweta Pradara but here I have chosen comparative study between two single drugs i.e. Amalaki beeja kalka with madhu and sharkara and Rohitaka Moola Kalka with water which not only treats symptoms but also does samprapti bhanga. Therefore I have selected 60 patients aged between 18-45 years, patients should be selected on the basis of inclusion and exclusion criteria. The trial will be of 3 consecutive months and follow up will be done after 3 days then after each months. Cured after 3 months patient gets 80-100percent relief from sign and symptoms. |