| CTRI Number |
CTRI/2025/04/085532 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of Daruharidra and Amalaki beej in Shwetapradara (abnormal vaginal discharge) |
|
Scientific Title of Study
|
Randomised comparitive clinical study to evaluate the efficacy of Daruharidra and Amalaki Beej in Shwetapradara w.s.r to abnormal vaginal discharge |
| 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 Karishma Bhadra |
| Designation |
PG Scholar Of Dravya Guna Vigyan Vibhag |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
Department of Dravyaguna Vigyan, Madan Mohan Malviya Government Ayurved College Ambamata Scheme Radaji Circle Udaipur Rajasthan 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
8286717784 |
| Fax |
|
| Email |
karishbhadra2209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Kumar Sharma |
| Designation |
Professor and Head Of Department Of Dravya Guna Vigyan Vibhag |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
Department of Dravyaguna Vigyan, Madan Mohan Malviya Government Ayurved College Ambamata Scheme Radaji Circle Udaipur Rajasthan 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929093470 |
| Fax |
|
| Email |
drashwinisharma1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karishma Bhadra |
| Designation |
PG Scholar Of Dravya Guna Vigyan Vibhag |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
Department of Dravyaguna Vigyan, Madan Mohan Malviya Government Ayurved College Ambamata Scheme Radaji Circle Udaipur Rajasthan 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
8286717784 |
| Fax |
|
| Email |
karishbhadra2209@gmail.com |
|
|
Source of Monetary or Material Support
|
| From Madan Mohan Malviya Government College Pharmacy,udaipur 313001. If not available from Madan Mohan Malviya Government College Pharmacy then from market |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved
College Ambamata Scheme Radaji Circle Udaipur Rajasthan 313001 |
| 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 Karishma Bhadra |
Government Ayurved Hospital Motichohattah |
OPD Room No 6, Govt Ayurved Hospital(Attached hospital to Madan Mohan Malviya Govt Ayurved College) Motichohattah Udaipur Rajasthan India 313001
Udaipur
RAJASTHAN |
8286717784
karishbhadra2209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madan Mohan Malviya Government Ayurved College Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Daruharidra, Reference: Gadanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki Beej, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Female patients with signs and symptoms of shwetapradara (abnormal vaginal discharge)
Age between 18 to 50 female patient
Female who are willing to participate |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Patients with known history of STD
Abnormal uterine bleeding
vaginal discharge occurring due to intrauterine contraceptive device
Patients with Oral Contraceptive PillS
Patients with ca cervix and other gynacological problems like ovarian cyst, uterine prolapse, uterine fibromyoma etc
5)Patients with Oral Contraceptive PillS
6) Patients with ca cervix and other gynacological problems like ovarian cyst, uterine prolapse, uterine fibromyoma, etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the signs and symptoms of sveta pradara (Abnormal vaginal discharge) - Yonigata sravah, varna, vedana, kandu, katishula, dourbalya, mutradaha, consistency of vaginal discharge, yoni dourgandhya, vaginal ph |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| identification & authentication of drugs |
15 days, 30days, 45days,60 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
|
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="1"
Months="0"
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
|
This Study is about Pharmacognostical and Clinical study of Daruharidra and Amlaki beej in Shwetpradara W.S.R to Abnormal vaginal discharge.There will be 2 Groups for the study,
In Group A - Druharidra choorna 3mg ( one time ) = BD = 6 gm/day will be given. In Group B - Amlaki beej choorna 3mg ( one time ) = BD = 6 gm/day will be given.
Trial will be conduct for a period of 2 months (60 days ) Follow up of the case will be after every 15 days that is 4 times ( At 15 days ,At 30 days ,At 45 days, At 60 days) during treatment. Final assessment will be done after completion of 2 months of treatment course on the basis of subjective, objective assessment and laboratory investigation. The data will be analyzed scientifically and statistically |