| CTRI Number |
CTRI/2024/09/074441 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Ayurvedic Enema Therapy And Kakoli Churna in Reduced Sperm Count in Men |
|
Scientific Title of Study
|
Clinical study on combined effectiveness of chatuh prasrutika basti(modified kala basti schedule) and kakoli churna in kshina shukra (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 |
Shivam kumar |
| Designation |
Post graduate scholar |
| Affiliation |
Patanjali Bhartiya ayurvigyan evam anusandhan sansthan haridwar uttrakhand |
| Address |
OPD No 13 Patanjali Ayurved Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Roorkee Highway Haridwar 249405 Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9568568854 |
| Fax |
|
| Email |
girirajshivam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish KJ |
| Designation |
Professor and Head |
| Affiliation |
Professor Department of Kayachikitsa |
| Address |
OPD No 13 Patanjali Ayurved Hospital Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Delhi Roorkee Highway Haridwar 249405 Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9448646855 |
| Fax |
|
| Email |
girideepa@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam kumar |
| Designation |
Post graduate scholar |
| Affiliation |
Patanjali Bhartiya ayurvigyan evam anusandhan sansthan haridwar uttrakhand |
| Address |
OPD No 13 Patanjali Ayurved Hospital Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Delhi Roorkee Highway Haridwar 249405 Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9568568854 |
| Fax |
|
| Email |
girirajshivam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar |
| Address |
OPD No 13 Patanjali Ayurved Hospital Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Delhi Roorkee Highway Haridwar 249405 Uttarakhand |
| Type of Sponsor |
Private 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 Shivam Kumar |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
O.P.D. 13 Department of Kayachikitsa, Patanjali Ayurved hospital, Phase 1, Haridwar Road
Hardwar
UTTARANCHAL |
9568568854
girirajshivam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Patanjali Ayurved College |
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 | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak Siddhisthana -08/07, Procedure details: Poorva Karma: After passing faeces, urine and flatus, the Individual on empty stomach will be prepared with Abhyanga and Swedan. However, Individual shall not be very hungry.
Pradhana Karma: Individual will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight and relaxed. Then the Individual will be asked to flex his right leg over his fully extended left leg. Thereafter anus and enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered.
Paschata Karma: Individual will be advised to lie on his back i.e in supine position comfortably on the bed. Individual will be advised to empty his bowel after getting urge for defecation.
)
(1) Medicine Name: Chatuhprasrutika Basti, Reference: Charak Siddhisthana -08/07, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 420(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kakoli churna, Reference: Charak sutrasthana 4/8/19, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -warm milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
• Any major disorder like CRF, CAD, Liver Cirrhosis, Cancer etc.
• Varicocele
• Sexually transmitted disease patients presenting with organic defects.
• Postsurgical procedure or post trauma on the genital organs.
• Undescended testis
• Testicular cancer and cancer treatment.
|
|
| ExclusionCriteria |
| Details |
• Any major disorder like CRF, CAD, Liver Cirrhosis, Cancer etc.
• Varicocele
• Sexually transmitted disease patients presenting with organic defects.
• Postsurgical procedure or post trauma on the genital organs.
• Undescended testis
• Testicular cancer and cancer treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Semen parameters
1. Sperm Count
2. Sperm Motility
3. Total Abnormal Sperm (%)
4. Semen Volume
5. Semen Viscosity
6. Semen Liquifaction Time
7. Semen pH
|
First Follow-up 4 weeks
Second Follow-up 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical signs & symptoms : oligozoospermia (Kshina Shukra)
1. Inability to conceive
2. Sexual parameters
3. Quality of life |
First Follow-up : 4 weeks
Second Follow-up : 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
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a single arm evaluation of Chatuhprasrutika basti and kakoli churna in Kshina Shukra (Oligozoospermia). This will be conducted on 30 randomly selected patients from OPD of Kayachiktsa department of Patanjali Ayurved Hospital, Haridwar. First follow-up during treatment- 30 days and second
follow-up at the end of treatment i.e. 45 days. Assessment will be done on the basis of subjective and objective parameters as discussed earlier. |