| CTRI Number |
CTRI/2024/12/078398 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative clinical evaluation of Bhumyamalaki Churna and Amlakibeeja Churna in the management of Shwetapradara with special reference to Bacterial Vaginosis. |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the effect of Bhumyamalaki churna and Amlakibeeja churna in Shwetapradara w.s.r. to Bacterial Vaginosis. |
| 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 PRADNYA HANUMANT RAUT |
| Designation |
PG SCHOLAR |
| Affiliation |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE PADMA AYURVEDA HOSPITAL AND RESEARCH CENTRE TERDAL |
| Address |
DEPARTMENT OF PTSR
OPD NUMBER 3
FLOOR NUMBER 2
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE PADMA AYURVEDA HOSPITAL AND RESEARCH CENTRE TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9860103222 |
| Fax |
|
| Email |
pradnyaraut60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUKANYA PATIL |
| Designation |
PROFESSOR |
| Affiliation |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE TERDAL |
| Address |
DEPARTMENT OF PTSR
FLOOR NUMBER 2
OPD NUMBER 3
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9480151454 |
| Fax |
|
| Email |
drsukanyapatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRADNYA HANUMANT RAUT |
| Designation |
PG SCHOLAR |
| Affiliation |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE TERDAL |
| Address |
DEPARTMENT OF PTSR
OPD NO 3
FLOOR NO 2
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9860103222 |
| Fax |
|
| Email |
pradnyaraut60@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College
Padma Hospital
Room number 3
Floor Number 2
Department of PTSR |
|
|
Primary Sponsor
|
| Name |
DR PRADNYA HANUMANT RAUT |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE TERDAL
PADMA AYURVEDIC HOSPITAL
DEPARTMENT OF PTSR
ROOM NUMBER 3
FLOOR NUMBER 2
TERDAL
587315
BAGALKOT DISTRICT
KARNATAKA
|
| 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 PRADNYA HANUMANT RAUT |
PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE TERDAL |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE PADMA AYURVEDA HOSPITAL AND RESEARCH CENTRE TERDAL
DEPARTMENT OF PTSR
FLOOR NUMBER 2
ROOM NUMBER 3
Bagalkot
KARNATAKA |
9860103222
pradnyaraut60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
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: Bhumyamalaki churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Tandulodaka), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amalakibeeja churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Tandulodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients with Pratyatma Lakshana’s of Shwetapradara (Bacterial
vaginosis) – Yonigata Shwetasrav, Yonikandu, Daurgandhya, Yonidaha
and Katishoola.
• Patients between age group 18 years to 40 years.
• Irrespective of marital status. |
|
| ExclusionCriteria |
| Details |
Patients with Systemic disorder like DM.
• K/C/O Reproductive Organs Congenital abnormalities.
• K/C/O STD, PID, Women having Benign and Malignant tumors.
• Pregnant and lactating women, OCP using women.
• Women already diagnosed with Cervical fibroid, Uterine Fibroid. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of trial drug on Shwetapradara (Bacterial Vaginosis) assessed by the assessment parameters |
15th day, 30th day, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in associated symptoms of Shwetapradara (Foul smell, Vaginal Itching, burning sensation at vagina, lowback ache):
Graded improvement based on patient-reported outcomes.
pH of vaginal discharge (measured using a pH strip test).
Whiff test result (positive/negative). |
Baseline (Day 0)
Follow-up on Day 15, Day 30, & Day 45. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/12/2024 |
| 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="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
|
Study Title:
A Comparative Clinical Study to Evaluate the Effect of Bhumyamalaki Churna and Amlakibeej Churna in Shwetapradara with Special Reference to Bacterial Vaginosis Clinical Trial Registration Number:
(To be assigned) Principal Investigator:
Dr. Pradnya Hanumant Raut, 2 nd Year PG Scholar, Department of Prasuti Tantra and Stree Roga, SDM Trust’s Ayurvedic Medical College, Terdal. Study Objectives: - To evaluate the efficacy of Bhumyamalaki churna in the treatment of Shwetapradara (Bacterial Vaginosis).
- To evaluate the efficacy of Amlakibeej churna in the treatment of Shwetapradara.
- To compare the efficacy of Bhumyamalaki churna and Amlakibeej churna in Shwetapradara.
Study Design:
A randomized controlled clinical trial. Sample Size:
40 female participants, divided into two groups: - Group A (20 patients): Treated with Bhumyamalaki churna (6g twice a day for 30 days).
- Group B (20 patients): Treated with Amlakibeej churna (6g twice a day for 30 days).
Intervention: - Group A: Bhumyamalaki churna with tandulodak as an anupana (before food).
- Group B: Amlakibeej churna with tandulodak as an anupana (before food).
Inclusion Criteria: - Women aged 18–40 years presenting with the characteristic symptoms of Shwetapradara (Bacterial Vaginosis), including abnormal vaginal discharge, itching, foul smell, and associated discomfort.
Exclusion Criteria: - Patients with systemic disorders, congenital reproductive organ abnormalities, sexually transmitted diseases, or malignancies.
- Pregnant or lactating women, women with uterine or cervical fibroids, or those on oral contraceptives.
Outcome Measures: - Subjective parameters such as vaginal discharge, odor, itching, burning sensation, and pain.
- Objective assessments include the amount and type of discharge, pH level, and Whiff test.
Trial Duration:
45 days (with assessments on day 15, day 30, and final follow-up on day 45). Ethical Approval:
The study has received approval from the institutional ethics committee. |