| CTRI Number |
CTRI/2022/05/042708 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
12/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy Evaluation of SARVONUTRA M as Male Wellness Agent |
|
Scientific Title of Study
|
Double Blind Placebo Controlled Study to Evaluate Efficacy of Innovative Natural Formulation (Sarvonutra M) to Enhance Performance, Endurance Conjugal Life, and Quality of Life in Men |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Bhat |
| Designation |
Professor |
| Affiliation |
Karnataka Ayurveda Medical College |
| Address |
Dept of Kayachikitsa
Karnataka Ayurveda Medical College Ashok Nagar Mangalore
Karnataka Ayurveda Medical College Ashok Nagar Mangalore
Dakshina Kannada
KARNATAKA
575006
India |
| Phone |
9113883204 |
| Fax |
|
| Email |
ravi.ayurveda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BAIDYANATH MISHRA |
| Designation |
PRESIDENT NATURAL PRODUCTS |
| Affiliation |
SARVOTHAM CARE LIMITED |
| Address |
1 20 248 Umajay complex
1st floor Rasoolpura
Secunderabad
Hyderabad
TELANGANA
500003
India |
| Phone |
7975843079 |
| Fax |
|
| Email |
dr.mishra@sarvothamcare.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SRINIVASA |
| Designation |
AGM NATURAL PRODUCTS R&D |
| Affiliation |
SARVOTHAM CARE LIMITED |
| Address |
1 20 248 Umajay complex
1st floor Rasoolpura
Secunderabad
Hyderabad
TELANGANA
500003
India |
| Phone |
8106204303 |
| Fax |
|
| Email |
srinur.y@sarvothamcare.com |
|
|
Source of Monetary or Material Support
|
| fund flow from SARVOTHAM CARE LIMITED |
|
|
Primary Sponsor
|
| Name |
SARVOTHAM CARE LIMITED |
| Address |
1-20-248, Umajay complex,
1st floor, Rasoolpura
Secunderabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Ravi |
KARNATAKA AYURVEDA MEDICAL COLLEGE |
Department of kayachikitsa, Ground Floor, KARNATAKA AYURVEDA MEDICAL COLLEGE
Dakshina Kannada
KARNATAKA |
9945898138
kamc.kect@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee - karnatak Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N538||Other male sexual dysfunction. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: sarvonutra m, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1000(mg), Frequency: od, Bhaishajya Kal: Grasantara bhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: -na | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: sarvonutra M as placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1000(mg), Frequency: od, Bhaishajya Kal: Grasantara bhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
a) Healthy male individuals.
b) Infertility and low conjugal life for more than 3 months diagnosed with oligospermia (defined by <15 million sperms/ml) as per the WHO standards
c) No past history of renal, hepatic, or any other chronic illness in the past
d) Normal liver, and renal function tests.
e) Patients freely willing and able to provide written informed consent, willing to follow study procedures. |
|
| ExclusionCriteria |
| Details |
a) Complete azoospermia in the pre-treatment samples
b) Any congenital anomaly resulting in oligospermia
c) Evidence of male accessory gland infection
d) Any recent medical or surgical illness
e) Hormone/any other treatment for promoting fertility in the last three months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Evaluate the improvements of quality of conjugal life.
b) Reduction in premature ejaculation
c) Arousal with lesser foreplay
d) Improvement in seminal output and motility
e) If any conceptions during clinical trial |
6 - 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Changes in mood swing
b) Better sleep
c) Improvement in Conjugal Life & Wellbeing |
6 - 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/05/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The back ground of the trial is to evaluate the efficacy of this proprietary and patented formulation addressing the quality of life in men and sustaining a happy family life |