| CTRI Number |
CTRI/2024/05/067380 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Novel Method to Standardize the Oral Thin Film Prepared from the Ayurveda Drugs for the patients of Oligospermia |
|
Scientific Title of Study
|
Oral Thin Film - A Novelty in the Ayurveda Practice (A Pilot Study) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sorathia Meet Suresh |
| Designation |
U.G. Student |
| Affiliation |
G. J. Patel Institute of Ayurveda Studies and Research |
| Address |
Department of Kayachikitsa, G.J.Patel Institute of Ayurvedic Studies and Research, New Vallabh Vidhyanagar, Anand, Gujarat 388120
Anand GUJARAT 388120 India |
| Phone |
9687238006 |
| Fax |
|
| Email |
ssorathiameet@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Remesh Chandran |
| Designation |
Assistant Professor, Dept. of Kayachikitsa |
| Affiliation |
G. J. Patel Institute of Ayurveda Studies & Research |
| Address |
Dept. of Kayachikitsa, G. J. Patel Institute of Ayurveda Studies & Research, GIDC, ADIT Campus, New Vallabh Vidhyanagar, Anand, Gujarat 388345
Anand GUJARAT 388345 India |
| Phone |
7012236368 |
| Fax |
|
| Email |
remeshchandran39@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Remesh Chandran |
| Designation |
Assistant Professor, Dept. of Kayachikitsa |
| Affiliation |
G. J. Patel Institute of Ayurveda Studies & Research |
| Address |
Dept. of Kayachikitsa, G. J. Patel Institute of Ayurveda Studies & Research, GIDC, ADIT Campus, New Vallabh Vidhyanagar, Anand, Gujarat 388345
Anand GUJARAT 388345 India |
| Phone |
7012236368 |
| Fax |
|
| Email |
remeshchandran39@gmail.com |
|
|
Source of Monetary or Material Support
|
| G. J. Patel Institute of Ayurveda Studies and Research, Anand |
|
|
Primary Sponsor
|
| Name |
Mr Meet Sorathia |
| Address |
Dept. of Kayachikitsa, G.J .Patel Institute of Ayurveda Studies and Research, New Vallabh Vidhyanagar, Anand - 388345, Gujarat. |
| 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 Remesh Chandran |
G. J. Patel Institute Of Ayurveda Studies And Research |
Department of Kayachikitsa, GJPIASR, New Vallabh Vidhyanagar, Anand, Gujarat 388345 Anand GUJARAT |
7012236368
remeshchandran39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G.J. Patel Institute of Ayurvedic Studies And Research & S.G. Patel Ayurveda Hospital & Maternity Home Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: OTF, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 150(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
Patients of Age 21-45 Years, Primary or Secondary Infertility, Prediagnosed Case of Infertility |
|
| ExclusionCriteria |
| Details |
Patient of Varicocele, STDs, Azoospermia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Oral Thin Film is effective in increasing the semen counts. |
7 Days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Oral Thin Film is effective in the Oligospermia. |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" 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
|
Ayurveda, the science of life aims maintaining the health of the healthy individuals and curing the diseased ones. To fulfill this aim, there are eight parts of the Ayurveda known as Ashtanga Ayurveda. Ashtanga Ayurveda works at various aspects of the individual to promote health. Ayurveda described the treatment protocol either in the form of Antah Parimarjana Chikitsa or in the form of Bahir Parimarjana Chikisa. Antah Parimarjana Chikitsa (Internal therapeutics) incorporates the Sodhana Karma (Purification measures) i.e. Vamana, Virechana, Basti, Nasya, Dhoompana, Gandusha, Kavala etc. as well as the Shamana Karma (Pacification measures) by prescribing various medicines depending upon the condition of the disease. While the Bahirparimarjana Chikitsa includes all the external therapeutics such as Lepa, Upnaha, Pariseka, Abhyanga, Pichu, Agnikarma etc. Therfore both the Bahir Parimarjana Chikitsa & Antah Parimarjana Chikitsa acts as the drug delivary system in the field of Ayurveda. If we look at the Allopathy System of Medicine, we can find various routes of drug administration. Medications can be taken in a variety of ways – by swallowing, by inhalation, by absorption through the skin, or by injection. Each method has its own advantages and disadvantages. However improving current delivery methods or designing new ones can enhance the use of existing medications. Till date there is no development of the oral drug delivery system in the form of Oral Thin Films in the field of Ayurveda. The same intervention of designing new forms of drug administration to enhance the use of existing medications will play a significant role in the field of Ayurveda. Oral thin film is the most advanced and promising new approaches for drug delivery as it offers more flexibility and comfort. ASU drugs administered in the form of Oral Thin Film are the novel approach in oral drug delivery systems in the field of Ayurveda.
Today there are various routes for administration of the drugs, which includes sublingual route too. Every route has its own pros and cons. If we look at the pediatric as well as geriatric age group patients, it becomes difficult to administer drugs in the form of tablets, pills or parental route. Even in some patients we face difficulty in finding the venous vessels to administer the drugs though parental route. Though parental route is better compared to oral route as the drug can directly enter into the blood but the same may cause complications like thrombo-phlebitis, infection, damage to nerve or blood vessels etc. Therefore the drug administration in the form of Oral Thin Film sounds to be the better option in the pediatric as well as geriatric care. Hence this demands the new interventions in the field of the Ayurveda in the form of Oral Thin Film of the ASU drugs. We can analyze the efficacy and stability of the ASU drugs in the form of Oral Thin Film. Therefore in this study, we are incorporating the proven Ayurveda drugs in the form of the Oral Thin Films for the qualitative and quantitative production of the Shukra Dhatu in males. It is an initial step of incorporation of Ayurveda drugs for the Vajikarana purpose. Interventions of Ayurveda in the Modern Drug Delivery System will have a wide scope in the future. |