| CTRI Number |
CTRI/2024/07/070079 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of oligozoospermia in Ayurveda |
|
Scientific Title of Study
|
A clinical study to evaluate the safety and efficacy of shatavaryadi churna and shatpushpadi yapana vasti in the management of ksheen shukra w.s.r. oligozoospermia |
| 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 Sahil Sain |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Central
DELHI
10005
India |
| Phone |
87000751 |
| Fax |
|
| Email |
sahilsain7525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Central
DELHI
110006
India |
| Phone |
981057165 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Central
DELHI
110006
India |
| Phone |
981057165 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh, New Delhi-110005 |
| Type of Sponsor |
Government medical college |
|
|
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 Sujata Yadav |
Ayurvedic and Unani Tibbia College and Hospital |
Seminar Room,PG Department of Kayachikitsa
Central
DELHI |
9810571653
sujatakcdelhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia college and Hospital |
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 | Procedure | - | yApana-bastiH, यापन-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: SHATPUSPHADI YAPANA VASTI (Cha.Si.12/17(14)), Procedure details: 480ml of shatpusphadi yapana vasti for 15 days for two times with the break of 30days.)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: satavaryadi choorna, Reference: Yogratnakar/Vajeekaran adhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -ghrita, madhu and sharkara ), Additional Information: - | | 3 | Comparator Arm | Procedure | - | yApana-bastiH, यापन-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: SHATPUSPHADI YAPANA VASTI (Cha.Si.12/17(14)), Procedure details: 480ml of shatpusphadi yapana vasti for 15 days for two times with the break of 30days.)
(1) Medicine Name: satavaryadi choorna , Reference: Yogratnakar/Vajeekaran adhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 3 Months |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Male patients age between 20-50 years.
2. Patients having sperm count below 15 million per ml.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are known case of varicocele, accessory sex gland infection, sexually transmitted disease, nephrological pathology, severe systemic disease,genetic disorders such as klinfetter’s syndrome, etc.
2.Patients of payospermia and nacrospermia.
3.Patients of DM type 2.
4.Patients undergoing treatment for any psychiatric illness like Anxiety, Depression, Schizophrenia etc.
5.Patients with history of previous genital trauma leading to oligospermia.
6.Patients those are not fit for vasti karma i.e., patient suffering from piles,fissure,or other ano-rectal disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in semen count and quality in patient with ksheenshukra(oligozoospermia) |
Day 1,91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Signs and Symptoms of Ksheenshukra (oligozoospermia) |
Day1,91 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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="1"
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
|
Ksheena Shukra is a condition in which Shukra dhatu is decreased in quantity and quality as well.Vata and Pitta are the main Doshas responsible for the condition of Ksheenashukra.Oligozoospermia is the leading cause of infertility. The term Oligozoospermia or Oligospermia refers to the semen with low concentration of sperm and is a common finding in male infertility. Sperm count of less than 15 million sperm / ml is considered as the condition of Oligozoospermia.Oligozoospermia is one of the leading causes of infertility. Infertility is a social stigma; infertility affects the psychological harmony, sexual life and social function.
Aim of the study- To evaluate the effect of shatavaryadi choorna and shatpusphadi yapana vasti in ksheena shukra (Oligozoospermia).
|