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Trial registered on ANZCTR
Registration number
ACTRN12625000548437
Ethics application status
Approved
Date submitted
12/01/2025
Date registered
30/05/2025
Date last updated
30/05/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparison of efficacy of exosomes vs platelet rich plasma therapy in treatment of androgenetic alopecia
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Scientific title
Comparison of efficacy of exosomes vs platelet rich plasma therapy in treatment of androgenetic alopecia
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Secondary ID [1]
313686
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Androgenetic alopecia
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Condition category
Condition code
Skin
332803
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0
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study aims to compare the efficacy of exosomes versus PRP in the treatment of Androgenetic alopecia by using photographic assessment, hair pull test and patient self-assessment questionnaire over a period of 6 months.
The enrolled patients will be randomly divided into two groups using the lottery method, Group A and B, each with 40 participants.
GROUP A:
Group A will receive treatment with exosomes intradermally at 0,1 and 3 months. Exosomes used are GFC CELL, consist of Leucoexo 97% having GFC CELL EXO SCALP 9700 powder and EXO SCALP Pep9 solution. The scalp will be cleaned with spirit and nerve block will be given by using the local injection, lignocaine, by insulin syringe at supratrochlear, supraorbital, and occipital region. Exosomes will then be injected at a strength of 2 to 10 billion particles/5ml, at a dose of 0.1 ml/cm2 of scalp. Patients will be observed for 1-hour post procedure for any adverse effects and will be instructed not to wash or massage their hair and avoid heavy activities for 48 hours after the injection.
Exosomes will be administered by Dermatologist in the dermatology clinic, Combined Military Hospital, Quetta.
Participants will be assessed at 0,1, 3, and 6 months. Serial photographs will be taken at each assessment. The efficacy of both groups will be evaluated using the hair pull test, global photography, patient and physician satisfaction questionnaire.
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Intervention code [1]
330281
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Treatment: Other
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Comparator / control treatment
GROUP B:
Group B will receive monthly injections of Platelet Rich Plasma (PRP) for 6 months Before the treatment, patient will be instructed to clean the scalp and not apply any oil to their scalp. The scalp will be cleaned and nerve block would be administered. Under aseptic conditions, around 30ml of blood will be collected from the median cubital vein and transferred into a tube containing anticoagulant sodium citrate, blood will then be subjected to a soft spin at 1500 RPM for 10 minutes in a centrifuge machine which will separate the blood into 2 layers: the lower RBC layer; the upper plasma layer buffy coat. This tube will again be subjected to a second centrifugation at 3000 RPM for 10 minutes, allowing the platelet rich plasma to settle. Upper layer of platelet poor plasma and the lower layer of the PRP will be collected. PRP will be extracted in sterile insulin syringes and will be activated using calcium gluconate in a ratio of 1:9 and administered intradermally in doses of 0.1 to 0.2 ml each, spaced 1 cm apart, in inter follicular areas. Platelet poor plasma will then be sprinkled and lightly massaged at all administration sites.
Blood will be withdrawn 1 hour before administration of PRP on the same day. PRP will be administered by Dermatologist in the dermatology clinic, Combined Military Hospital, Quetta.
Participants will be assessed at 0,1, 3, and 6 months. Serial photographs will be taken at each assessment. The efficacy of both groups will be evaluated using the hair pull test, global photography, patient and physician satisfaction questionnaire.
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Control group
Active
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Outcomes
Primary outcome [1]
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Hair Loss
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Assessment method [1]
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Hair Pull Test: The hair pull test is performed 3 times by the same clinician where in a bundle of approximately 50-60 hair is grasped between the thumb, index and middle finger from the base close to the scalp. The hair is firmly tugged away from the scalp, and the extracted hair is counted in every session. More than six hairs or 10% of the total hair - “positive” Six or less hairs or <10% of the total hair - “negative”
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Timepoint [1]
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Group A will be assessed at 0,1 and 3 months Group B will be assessed monthly for 6 months
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Primary outcome [2]
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Hair Density
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Assessment method [2]
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Photographic Assessment: At the end of each session baseline and post treatment photographs will be taken. Multiple images will be taken to cover all areas of the scalp. Four different views the vertex, frontal, and temporal will be especially focused to ensure an increase in hair density, new hair growth, and any improvement in the bald area. Some topographic sites will be identified in order to guarantee that measurements will be taken from the same location. One point at the vertex, 2 cm medial to the hair whorl, will be used as the basis, and two locations in the frontal region, within 5 cm of the hairline at the left and right mid-pupil lines, will be taken into consideration. During these sessions, photographs of the same areas will be taken with the same digital camera, from the same distance and under the same light and flash. Patient Satisfaction Questionnaire: A standardized, self-administered hair growth questionnaire with three questions in the patient's language about therapy, efficacy, and satisfaction will be used by patients to assess the difference in hair on their scalp, Physician Global Assessment Dermatologist will assess the difference in patients’ hair thickness, growth and hair density by answering a questionnaire with 3 questions. Each question will be statistically relevant in determining the outcome of the study. . All these measures will be assessed together to determine hair density as a composite outcome.
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Timepoint [2]
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Group A will be assessed at 0,1 and 3 months Group B will be assessed monthly for 6 months
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Secondary outcome [1]
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Hair Growth
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Assessment method [1]
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Photographic Assessment: At the end of each session baseline and post treatment photographs will be taken. Multiple images will be taken to cover all areas of the scalp. Four different views the vertex, frontal, and temporal will be especially focused to ensure an increase in hair density, new hair growth, and any improvement in the bald area. Some topographic sites will be identified in order to guarantee that measurements will be taken from the same location. One point at the vertex, 2 cm medial to the hair whorl, will be used as the basis, and two locations in the frontal region, within 5 cm of the hairline at the left and right mid-pupil lines, will be taken into consideration. During these sessions, photographs of the same areas will be taken with the same digital camera, from the same distance and under the same light and flash. Patient Satisfaction Questionnaire: A standardized, self-administered hair growth questionnaire with three questions in the patient's language about therapy, efficacy, and satisfaction will be used by patients to assess the difference in hair on their scalp, Physician Global Assessment Dermatologist will assess the difference in patients’ hair thickness, growth and hair density by answering a questionnaire with 3 questions. Each question will be statistically relevant in determining the outcome of the study. . All these measures will be assessed together to determine hair growth as a composite outcome.
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Timepoint [1]
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Group A will be assessed at 0,1 and 3 months Group B will be assessed monthly for 6 months
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Eligibility
Key inclusion criteria
Inclusion criteria
Clinical diagnosis of AGA
Age range of 18-60 years
Platelets count more than 150, 000 /µl to 450,000/ µl
Patients with Hamilton-Norwood Grade 2-5 or Ludwig scale Grade 1-3
Patients who haven’t received topical or systemic treatments for AGA within 3 months prior to the study
Patient who gave consent for the study
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria
Patients with other causes of hair loss fungal infection such as fungal infection, inflammatory or scarring alopecia, hyper-androgenism, telogen effluvium or other hormonal disorders
Patients with history of severe systemic disease (renal, cardiovascular hepatic and lungs) or active cancers
Pregnant or breastfeeding patients
Patients having known hypersensitivity to exosomes
Patients that are immunodeficient or are undergoing immunosuppressive therapy
Patients on anticoagulation or having bleeding disorders such as thrombocytopenia and anemia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers were used
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will draw a piece of paper from an opaque container to determine which treatment they will be allocated to
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The sample size for this study was calculated using the WHO calculator and following parameters:
Level of significance (a): 5%
Power of the test (1-ß): 80%
Anticipated Population Proportion 1 (P1): (0.743)1
Anticipated Population Proportion 2 (P2): (0.473)8
Sample size (n): 40 in each group
Total sample size for study will be: 80
Demographic data will be summarized using descriptive statistics. Mean and standard deviation were calculated for the quantitative variables like age and the duration of baldness. Frequency and percentage will be calculated for qualitative variables like gender, response to treatment, occurrence of adverse events. The quantitative variables will be compared using an independent t-test, while the qualitative outcome variable will be compared using a Chi-square/Fisher's exact test. The standard for determining statistical significance will be two-sided, p = 0.05. SPSS version 29 will be used to enter and evaluate the data.
Hair Pull Test: The hair pull test is performed 3 times by the same clinician where in a bundle of approximately 50-60 hair is grasped between the thumb, index and
middle finger from the base close to the scalp. The hair is firmly tugged away from the scalp, and the extracted hair is counted in every session. More than six hairs or 10% of the total hair - “positive” Six or less hairs or 50%
Physician Global Assessment
Dermatologist will assess the difference in patients’ hair thickness, growth and hair density by answering a questionnaire with 3 questions. Each question will be statistically relevant and held significant efficacy in determining the outcome of the study. Clinical response will be interpreted as:- No change 0% Fair 0-25% Good 25-50% Excellent >50%
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/01/2025
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
80
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Accrual to date
50
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Final
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Recruitment outside Australia
Country [1]
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Pakistan
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State/province [1]
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Balochistan
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Dr Maira Wajahat - Combined Military Hospital Quetta
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Address [1]
318150
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Country [1]
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Pakistan
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Primary sponsor type
Individual
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Name
Dr Maira Wajahat - Combined Military Hospital Quetta
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Address
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Country
Pakistan
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Secondary sponsor category [1]
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Individual
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Name [1]
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DR NAJIA AHMED - Combined Military Hospital Quetta
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Address [1]
320533
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Country [1]
320533
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Pakistan
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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INSTITUTIONAL ETHICAL REVIEW BOARD (IERB) - CMH QUETTA
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Ethics committee address [1]
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COMBINED MILITARY HOSPITAL QUETTA, CHILTAN ROAD, QUETTA CANTONMENT, QUETTA, BALOCHISTAN, PAKISTAN. . ZIP CODE 87300
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Ethics committee country [1]
316795
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Pakistan
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Date submitted for ethics approval [1]
316795
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21/12/2024
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Approval date [1]
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23/12/2024
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Ethics approval number [1]
316795
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CMH QTA-IERB/60/2024
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Summary
Brief summary
OBJECTIVE This study aims to compare the efficacy of exosomes versus PRP in the treatment of Androgenetic alopecia by using photographic assessment, hair pull test and patient self-assessment questionnaire over a period of 6 months. HYPOTHESIS Exosomes are expected to be significantly more effective then PRP in treatment of AGA.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs MAIRA WAJAHAT
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Address
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COMBINED MILITARY HOSPITAL QUETTA. MOQ 2/2, Near Mess 10, Chiltan Road, Quetta Cantt, Quetta, Balochistan, Pakistan, Zip Code 87300
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Country
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Pakistan
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Phone
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+923317690447
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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MAIRA WAJAHAT
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Address
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COMBINED MILITARY HOSPITAL,QUETTA. MOQ 2/2, Near Mess 10, Chiltan Road, Quetta Cantt, Quetta, Balochistan, Pakistan, Zip Code 87300
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Country
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Pakistan
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Phone
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+923317690447
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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MAIRA WAJAHAT
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Address
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COMBINED MILITARY HOSPITAL. MOQ 2/2, Near Mess 10, Chiltan Road, Quetta Cantt, Quetta, Balochistan, Pakistan, Zip Code 87300
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Country
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Pakistan
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Phone
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+923317690447
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24439
Ethical approval
New erc maira.pdf
24440
Other
Abbreviated protocol including consent form, data ...
[
More Details
]
Draft 1 - Copy 2.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF