Protocol summary

Study aim
The study evaluated the efficacy of an Ayurvedic medicine regimen in managing symptoms of vaginal discomfort among women
Design
Pragmatic, community based, parallel group, single blinded, randomized controlled trial. Total 65 patients will be enrolled. Patients who met our inclusion criteria will be randomized into three groups.
Settings and conduct
At Noreen Nishat Welfare Hospital ,Khanewal ,Pakistan after approval for the study design granted by the Review Board and the Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Participants/Inclusion and exclusion criteria
Females of aged 16-55 years, with symptoms of abnormal vaginal discharge, excessive vaginal irritation, and itching, will be chosen for the study. Strict exclusions included pregnant women (due to altered vaginal flora and fetal safety concerns), those with prolapsed uterus (potential impact on symptoms), history of malignancy (to avoid treatment-related complications), severe illnesses (to maintain study integrity), and individuals with known allergies (to prevent confounding reactions)
Intervention groups
Participants will be assigned to three groups: Positive Control (G1) will receive oral Metro gel (metronidazole, 5 grams/day for 5 days), Negative Control (G2) will receive no allopathic medicine (distilled water), and Experimental Group (G3) will recieve daily ayurvedic medicine (10 grams/day for 30 days)
Main outcome variables
Primary symptoms will be assessed included excessive vaginal discharge, itching, swelling, redness, and unpleasant odor. Secondary symptoms evaluated will be back pain, constipation, loss of appetite, painful intercourse, and general well-being.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N8
Registration date: 2024-08-20, 1403/05/30
Registration timing: retrospective

Last update: 2024-08-20, 1403/05/30
Update count: 0
Registration date
2024-08-20, 1403/05/30
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2024-08-19, 1403/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploring The Combined Therapeutic Effects Of Ayuvedic Herbal Formulation Against Leucorre
Public title
Therapeutic Effects Of Ayuvedic Herbal Formulation Against Leucorre
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 16-55 year Symptoms of abnormal vaginal discharge Excessive vaginal irritation Vaginal itching Females
Exclusion criteria:
Pregnant women (due to altered vaginal flora and fetal safety concerns) Those with prolapsed uterus (potential impact on symptoms), History of malignancy (to avoid treatment-related complications) Severe illnesses (to maintain study integrity) Individuals with known allergies (to prevent confounding reactions).
Age
From 16 years old to 55 years old
Gender
Female
Phase
1
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 65
Randomization (investigator's opinion)
Randomized
Randomization description
This randomization will be done by computer-generated numbers to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator.
Blinding (investigator's opinion)
Double blinded
Blinding description
Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
Bosan Road
City
Multan
Postal code
66000
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
2024/IRB/3/MIMAS/05

Health conditions studied

1

Description of health condition studied
Leucorre:Diseases of the genitourinary system
ICD-10 code
N00-N99
ICD-10 code description
Leucorre:Diseases of the genitourinary system

Primary outcomes

1

Description
Excessive vaginal discharge
Timepoint
1 month
Method of measurement
The whiff test detected bacterial vaginosis through the presence of a fishy odor, and Gram staining identified bacterial species present in vaginal discharge

2

Description
Vaginal discharge examination
Timepoint
1 month
Method of measurement
The pH test measured vaginal acidity (normal range 3.8-4.5), the whiff test detected bacterial vaginosis through the presence of a fishy odor, and Gram staining identified bacterial species present in vaginal discharge

Secondary outcomes

1

Description
Back pain
Timepoint
1 month
Method of measurement
Visual Analog Scale

2

Description
Constipation, loss of appetite, painful intercourse and general well-being.
Timepoint
1 month
Method of measurement
By asking questions and discussing with patients

Intervention groups

1

Description
Control group: Positive Control (G1) received oral Metro gel (metronidazole, 5 grams/day for 5 days)
Category
Treatment - Drugs

2

Description
Control group: Negative Control (G2) received no allopathic medicine (distilled water)
Category
Treatment - Drugs

3

Description
Intervention group: Experimental Group (G3) received daily ayurvedic medicine (10 grams/day for 30 days)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Noreen Nishat Welfare Hospital, Khanewal, Pakistan
Full name of responsible person
Mashhud-Ul-Hasan Abid
Street address
Khanewal
City
Khanewal
Postal code
58150
Phone
+92 301 7412473
Email
mashhud.biochemist@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences Multan
Full name of responsible person
Mashhud-Ul-Hasan Abid
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 301 7412473
Email
mashhud.biochemist@gmail.com
Grant name
Student fund
Grant code / Reference number
MIMAS/06/05/Rabish
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences Multan
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Mashhud-Ul-Hasan Abid
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 301 7412473
Email
mashhud.biochemist@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture, Multan, Pakistan
Full name of responsible person
Imran Ahmad Khan
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Old Shujabad road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Rabish Rafique
Position
Final year student BS (hons.)
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 308 0646042
Email
rabishmimas@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
N/A
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...