| CTRI Number |
CTRI/2021/02/031190 [Registered on: 10/02/2021] Trial Registered Prospectively |
| Last Modified On: |
30/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Boostex Forte to Treat for Erectile Dysfunction and Premature Ejaculation. |
|
Scientific Title of Study
|
An Open Label, Prospective, Non- Comparative Single Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Boostex Forte capsule in Erectile dysfunction, Premature Ejaculation and associated conditions in Adult Males. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/SDF/057/20 Version no: 03 Dated 09-Jan-21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Raam Clinic |
| Address |
Room no 3,
Department of General/Family Medicine
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Raam Clinic |
| Address |
Room no 3,
Department of General/Family Medicine
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Raam Clinic |
| Address |
Room no 3,
Department of General/Family Medicine
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| SG Phyto Pharma Private Limited
532/1, Nilgiri Apartment, Plot 3 ‘E’,
Rajendranagar, Ring Road,
Kolhapur 416004/1
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
SG Phyto Pharma Private Limited |
| Address |
532/1, Nilgiri Apartment, Plot 3 ‘E’, Rajendranagar, Ring Road, Kolhapur 416004/1 Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024. |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Room no 1
Department of General/Family Medicine
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024.
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N529||Male erectile dysfunction, unspecified. Ayurveda Condition: DHVAJABANGAJAKLAIBYAM, (2) ICD-10 Condition:F524||Premature ejaculation. Ayurveda Condition: SUKRAGATAVATAH, (3) ICD-10 Condition:R37||Sexual dysfunction, unspecified. Ayurveda Condition: KLAIBYAM, (4) ICD-10 Condition:F529||Unspecified sexual dysfunction notdue to a substance or known physiological condition. Ayurveda Condition: KLAIBYAM, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Boostex Forte Capsules |
Dose : 2 Capsules
Dosage : 2 BID for 30 Days
Route of Administration : Oral
Treatment Duration: 30 Days
|
| Comparator Agent |
Not applicable as it is a non- comparative single arm study. |
Not applicable as it is a non- comparative single arm study. |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Adult males aged between 25 and 60 years (both ages inclusive) with known history or complaint of sexual dysfunction not limited to
- Erectile Insufficiency
- Premature Ejaculation
- Ability to achieve and maintain erection
- Psychic Functional Impotency
- Decreased Libido
- History of decreased/insufficient sperm count, motility and health.
2. Subjects who are in a monogamous, heterosexual relationship
3. Subjects with or without children.
4. Subjects who have scored a total of lesser than equal to on the International Index of Erectile Function Domain A at the time of screening
5. Subject or LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
7. Subjects who are willing to give all forms of medications or therapies for sexual dysfunction – oral, topical etc for the duration of the clinical study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known hypersensitivity to herbal investigational product or its constituents.
2. Subjects with current or chronic infection not limited to urinary tract infection, chronic renal infection.
3. Subjects on medications or herbal supplements for sexual dysfunction.
4. Subjects with hypogonadism or anatomical deformities of the penis such as severe penile fibrosis or Peyronie disease or phimosis.
5. Subjects who are currently on medications that are known to cause sexual dysfunction- cimetidine, spironolactone, thiazides, adrenergic blockers, anti- depressants etc
6. Subjects with immunucompromised state complications.
7. Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
8. Any significant medical condition e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc. , any medical condition that is unstable or poorly controlled or other factor e.g., planned relocation that the Investigator felt would interfere with study evaluations and study participation.
9. Subjects who have participated in any clinical study within 3 months from the date of enrolment.
10. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
11. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1. International Index of Erectile Function (IIEF): Total Score of greater than equal to 60.
2. Index of Premature Ejaculation: Total Score of greater than equal to 35
3. Boostex Forte: Quality of Life Questionnaire: Total Score of greater than equal to 10
4. International Index of Erectile Function (IIEF) : Total Score of greater than equal to 60
5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Total Score of greater than equal to 35
|
1. International Index of Erectile Function (IIEF): Day 1, Day 30.
2. Index of Premature Ejaculation: Day 1, Day 30.
3. Boostex Forte: Quality of Life Questionnaire: Day 1, Day 30. Telephonic Day 45, Day 60
4. International Index of Erectile Function (IIEF) : Telephonic Day 45, Day 60
5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Telephonic Day 45, Day 60
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2021 |
| Date of Study Completion (India) |
20/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Study Design : An Open Label, Prospective, Non Comparative Single Arm Clinical Study. Indication : Male Sexual Dysfunction (Erectile Dysfunction, Premature ejaculation, Decreased Libido) Investigational Product : Boostex Forte Comparator : None. Dose/Dosage : 2 BID for 30 days Subject Population : Adult males between 25 and 60 years of age with complaints of sexual dysfunction Number of Subjects : 80 Evaluable Subject Treatment Arms : Single Arm Study Treatment Duration : 30 Days treatment duration. Post Treatment Telephonic Follow up on Day 45 and Day 60 Assessments
1. International Index of Erectile Function
(IIEF) Domain A: Screening
2. Index of Premature Ejaculation: Day 1 and Day 30
3. Boostex Forte: Quality of Life
Questionnaire: Day 1, Day 30, Day 45, Day 60
4. International Index of Erectile Function
(IIEF) : Day 1, Day 30, Day 45, Day 60
5. Erectile Dysfunction Inventory of
Treatment Satisfaction (EDITS): Patient Version: Day 45, Day 60 Background of the study:
Sexual dysfunction is a complex medical issue with biological, psychological and social influences and is estimated to be highly prevalent in the global population. Natural aphrodisiacs are being intensified as the potency of herbal plan drugs is significant without the cause for side effects. Purpose of the study:
Boostex Forte is a classic combination of herbo mineral ingredients which possess spermatogenic properties, promite vigour and increase libido and also improves mental and physical health that in turn boost sexual desire and support performance in men. This clinical study is designed to evaluate the safety and effectiveness of Boostex Forte Capsules in improving male sexual dysfunction
|