| CTRI Number |
CTRI/2024/04/065757 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the effectiveness of Amukkara chooranam and aya chenduram in the management of aan maladu |
|
Scientific Title of Study
|
A clinical trial to evaluate the effectiveness of Amukkara chooranam and aya chenduram in the management of aan maladu (oligozoospermia) - 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 |
S ESWARI |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16, Department of kuzhandhai maruthuvam,National Institute of Siddha,Tambaram sanatorium,Chennai -47
Room no 16, Department of kuzhandhai maruthuvam, National Institute of Siddha, Tambaram sanatorium, chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
9080710669 |
| Fax |
|
| Email |
eshubsms4497@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Meenakshi Sundaram |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha,Tambaram sanatorium,Chennai
Department of kuzhandhai maruthuvam,National Institute of Siddha,Tambaram sanatorium,Chennai - 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9940266442 |
| Fax |
- |
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S ESWARI |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16, Department of kuzhandhai maruthuvam,National Institute of Siddha,Tambaram sanatorium,Chennai
Room no 16, Department of kuzhandhai maruthuvam, National Institute of Siddha, Tambaram sanatorium, chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
9080710669 |
| Fax |
- |
| Email |
eshubsms4497@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,Chennai -600047,Tamil Nadu,India |
|
|
Primary Sponsor
|
| Name |
DrSESWARI |
| Address |
Room no 16,Department of Kuzhandhai maruthuvam,National Institute of Siddha,Tambaram sanatorium,Chennai - 47. |
| 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 S Eswari |
Ayothidoss pandithar Hospital,National Institute of Siddha |
Room no 16, Department of kuzhandhai maruthuvam.
Chennai
TAMIL NADU |
9080710669
-
eshubsms4497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,NATIONAL INSTITUTE OF SIDDHA,CHENNAI 47 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: N461||Oligospermia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amukkara chooranam
Aya chenduram |
Amukkara chooranam
Aya chenduram |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Male infertile patients with age between 22-45 years
|
|
| ExclusionCriteria |
| Details |
1,Azoospermia-complete absence of sperm in the ejaculate
2. Aspermia-complete lack of semen
3. Necrospermia- spermatozoa in semen are dead
4. Clinical diagnosis of varicocele & hydrocele
5. History of undescended testis
6. Inguinal hernia on physical examination |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in the semen parameter after the medication |
At baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
01/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 the ability to achieve pregnancy after 12 months of regular unprotected intercourse, affects upto 15% of couple worldwide. Male factor solely contributes in about 20% of infertility couples or acting in conjugation with female fertility factor in 30% of infertility couples. Oligozoospermia refers specifically to the condition in which sperm concentration below the lower reference limit of 15 million sperm/mL of ejaculate. Oligozoospermia can be further classified as mild (between 10-15 million sperms/mL),moderate (between 5-10 million sperms/mL) and severe ( less than 5 million sperms/mL). According to Siddha Scholar Yugi muni symptoms like semen showing lack of sweetness, floating on water, absence of vitality & frothy micturation indicates Aan maladu [male infertility]. In Siddha, Thathu nashtam [Oligozoospermia] has not been described as a separate disease entity. There is no direct reference for the comparison of Thathu nashtam to oligozoospermia however its feature can be understood on the basis of the indirect references available in the Siddha literatures. The various nomenclature used in siddha texts in relation with Sukkilam the seventh udal thathu [physical constituent] can be compared to sperm and not semen alone since its function is reproducion. The term Thathu Rogam [vinthu vai patria 4 noi] denotes disease relating to sperm and Thathu kuraivu / Thathu pushti kuraivu denotes Oligozoospermia and hence the term Thathu nashtam can be compared to oligozoospermia of contemporary science as both are similar in terminology [oligo-low; zoospermia-spermatozoa in semen ; thathu – sperm; nashtam-lack, be deficient in]. |