| CTRI Number |
CTRI/2022/07/044015 [Registered on: 14/07/2022] Trial Registered Prospectively |
| Last Modified On: |
20/05/2023 |
| 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
|
Comparative Study of Pippalyadi Churna and Bhumyamlaki Churna in Leucorrhoea |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Pippalyadi Churna and Bhumyamlaki Churna in Shweta-Pradara (Leucorrhoea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravesh Tomar |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurveda University |
| Address |
Department of Prasuti Tantra evam Stree Roga Rishikul Campus Haridwar 249401 Uttarakhand
OPD No 9 Department of Prasuti Tantra Evam Stree Roga Rishikul Campus Haridwar 249401 uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9870899895 |
| Fax |
|
| Email |
praveshtomarlal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravesh Tomar |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurveda University |
| Address |
Department of Prasuti Tantra evam Stree Roga Rishikul Campus Haridwar 249401 Uttarakhand
OPD No 9 Department of Prasuti Tantra Evam Stree Roga Rishikul Campus Haridwar 249401 uttarakhand
UTTARANCHAL
249401
India |
| Phone |
9870899895 |
| Fax |
|
| Email |
praveshtomarlal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravesh Tomar |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurveda University |
| Address |
Department of Prasuti Tantra evam Stree Roga Rishikul Campus Haridwar 249401 Uttarakhand
OPD No 9 Department of Prasuti Tantra Evam Stree Roga Rishikul Campus Haridwar 249401 uttarakhand
UTTARANCHAL
249401
India |
| Phone |
9870899895 |
| Fax |
|
| Email |
praveshtomarlal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Uttarkhand Ayurveda University |
| Address |
OPD No 9 Department of Prasuti Tantra Evam Stree Roga Rishikul Campus Haridwar 249401 uttarakhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pooja Mehra |
Rishikul Campus |
Department of Prasuti Tantra evam Stree Rog, OPD No 9, IPD No 6, Rishikul Campus Uttarakhand Ayurveda University Haridwar
Hardwar
UTTARANCHAL |
8708092652
poojamehra6313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi Churna, Reference: Charak Samhita chikitsa sthan 30/84, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3.625(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: bhumyamalaki churna, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -tandulodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
48.00 Year(s) |
| Gender |
Female |
| Details |
Female patients of Age between 16 to 45 years.
Unmarried/Married Females.
Pratyatama Lakshanas of Shwetapradara (Cardinal feature of white discharge).
Patients who could attend follow up regularly.
|
|
| ExclusionCriteria |
| Details |
Female of age group below 16 years and above 45 years.
Patients presented with PUO (Pyrexia of unknown origin).
Patients those having bleeding disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
|  To evaluate the comparative effect of Pippalyadi Churna and Bhumyamalaki Churna in Shweta-Pradara (leucorrhoea). subjectively all signs and symptoms are given with grading depending upon there severity. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacerbation in sign and symptoms |
15 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2022 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Shweta-Pradara is a type of abnormal vaginal discharge. it can be correlated with Leucorrhoea in modern science. This study trial drug Pippalyadi churna and Bhumyamalaki churna to evaluate their comparative effects in Shweta Pradara. Pippalyadi Churna and Bhumyamalaki Churna will be given orally to the patient for 15 days . Duration of treatment is 30 days. patient will be taken from OPD No 9 PG Department of Prasuti Tantra Evam Stree Roga, Rishikul Campus Haridwar, Uttarakhand Ayurved University Harrawala, Dehradun |