| CTRI Number |
CTRI/2024/12/077864 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the ayurveda treatments in oligozoospermia |
|
Scientific Title of Study
|
Efficacy of vangadi yoga and kapikacchu churna in the management of oligozoospermia
A randomized controlled clinical trial
|
| 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 Rohan Mohandas |
| Designation |
Assistant Professor |
| Affiliation |
KAHERS Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department of Kayachikitsa, Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
7798677316 |
| Fax |
|
| Email |
rohaninsomaniac.4481@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas Kumar Shetty |
| Designation |
Principal and Professor Department of Kayachikitsa |
| Affiliation |
Shri B M kankanwadi Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa, Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi
Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhas Kumar Shetty |
| Designation |
Principal and Professor Department of Kayachikitsa |
| Affiliation |
Shri B M kankanwadi Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa, Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi
Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Kankanmwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Rohan Mohandas |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India 590003 |
| 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 Rohan Mohandas |
KLE Ayurveda Hospital and MRC Shahapur Belagavi |
OPD 21 Srishti Fertility OPD KLE Ayurveda hospital Shahapur Belagavi
Belgaum
KARNATAKA |
7798677316
rohaninsomaniac.4481@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of higher education and research ethics committee on human subjects for Ph.D research projects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vangadi Yoga, Reference: Rasa tarangini 18th chapter 59th shloka , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kapikacchu , Reference: Susruta samhita Chikitsa sthana 26th chapter Shloka no 35, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: milk with sugar Q S), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed cases of Oligozoospermia.
Subjects within the age group of 20 to 50 years.
Subjects either married or unmarried.
Subjects indicated for Koshta shodhana (Sadyo virechana )
Subjects who are ready to voluntarily sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
Subjects with uncontrolled /untreated metabolic disorders, long-standing infections, chronic liver & renal disease or any psychiatric illness.
Accessory sex gland infection , STD’s, testicular maldescent , Hydrocele , varicocele more then grade II, neoplasms, Subjects with recent history of Orchitis, Trauma and Acute febrile illness,
Diagnosed cases of Azoospermia.
Subjects exposed to environmental chemicals, thermal exposure, X-ray radiation and chemotherapeutic agents will be taken into consideration.
Subjects who have undergone Vasectomy and under long standing medications (Alpha blockers,SSRI’s, Steroids, androgens) be taken into consideration.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Sperm Count |
Baseline and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the Sperm motility
Sperm Morphology
|
Baseline and 45th Day |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
01/01/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Infertility is defined as: “A failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse Of all the sexually active couples, 12% to 15% are infertile, of which a male component can be identified 50% of the time either individually or along with the female component.Male infertility refers to a male’s inability to result pregnancy in a fertile female. “Male factor†infertility is seen as an alteration in sperm concentration and/or motility and/or morphology in at least one sample of two sperm analyses, collected 1 and 4 weeks apart. Males with sperm parameters below the WHO normal values are considered to have male factor infertility. The most significant of these are low sperm concentration (oligozoospermia) poor sperm motility (asthenozoospermia), and abnormal sperm morphology (teratozoospermia) Male infertility is an alarming global health issue that has not been researched or studied to truly understand its magnitude and prevalence. There is still a great need for further research into underlying etiology and treatment of male infertility.Ayurveda explains Vajikarana Chikitsa for the problems related to fertility and sexual functions. Vangadi yoga is One such formulation is mentioned in Rasatarangini, in the chapter of Vanga bhasma where in it is said that:vanga bhasma taken with the Shalmali and Abrakha Bhasma is Shukra Janana param i.e it is most potent in increasing the sperm count The present study is randomized controlled clinical trial with a sample size of 56 , 28 in each group one group will recieve vangadi yoga and other group will recieve control drug kapikacchu churna for duration of 45 day the participants will be assessed on baseline and 45th day by semen parameters |