| CTRI Number |
CTRI/2025/11/096821 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study To see the effect of two species of Roscoea in low sperm count |
|
Scientific Title of Study
|
Comparative clinical evaluation of two species of Roscoea in 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 |
Jai Shree Yadav |
| Designation |
Pg scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan haridwar uttarakhand |
| Address |
OPD No 29 Patanjali ayurved hospital patanjali yogpeeth phase 1 Bahadrabaad haridwar uttarakhand
OPD No 29 Patanjali ayurved hospital patanjali yogpeeth phase 1 Bahadrabaad haridwar uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7976841478 |
| Fax |
|
| Email |
jaiishree.yadavv100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramakant Mrade |
| Designation |
Professor and HOD |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan haridwar uttarakhand |
| Address |
OPD No 29 Patanjali Ayurved Hospital Patanjali Yogpeeth Phase 1 Bahadrabaad Haridwar Uttarakhand
OPD No 29 Patanjali Ayurved Hospital Patanjali Yogpeeth Phase 1 Bahadrabaad Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9720982896 |
| Fax |
|
| Email |
ramakant.marde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jai Shree Yadav |
| Designation |
Pg scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan haridwar uttarakhand |
| Address |
OPD No 29 Patanjali Ayurved Hospital Patanjali Yogpeeth Phase 1 Bahadrabaad Haridwar Uttarakhand
OPD No 29 Patanjali Ayurved Hospital Patanjali Yogpeeth Phase 1 Bahadrabaad Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7976841478 |
| Fax |
|
| Email |
jaiishree.yadavv100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand pin 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand |
| Address |
OPD No 29 Patanjali Ayurved Hospital Patanjali Yogpeeth Phase 1 Bahadrabaad Haridwar 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 Jai Shree Yadav |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD No 29 Patanjali Ayurved Hospital Patanjali Yogpeeth Phase 1 Bahadrabaad Haridwar Uttarakhand
Hardwar
UTTARANCHAL |
7976841478
jaiishree.yadavv100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kakoli Roscoea alpina, Reference: Raj Nighantu Guduchiyaadi varga shloka no 27, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Cow milk ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kakoli Roscoea purpurea , Reference: Raj nighantu guduchiyadi varga shloka no 27, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -cow milk ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Sperm count mild oligozoospermia (10-15 million sperms /ml) & moderate oligozoospermia
(5-10million sperms /ml)
2. Willing to sign the consent form and to participate in study.
3. Willing to give specimen of semen before and at the end of the clinical trial.
4. Abstinence during treatment. |
|
| ExclusionCriteria |
| Details |
1. Azoospermia, Aspermia, Necrospermia
2. Patients with abnormal liver and renal functions test.
3. Subject with history of severe systemic illness like chronic renal failure, coronary artery
disease, liver cirrhosis, cancer etc.
4. Varicocele, hydrocele, prostatitis, erectile dysfunction, male accessory gland infection.
5. History of undescended testis, mumps orchitis, inguinal hernia.
6. Known case of uncontrolled diabetes, hypertension, thyroid disease.
7. Sexually transmitted disease patients presenting with organic defects.
8. History of obstruction of ejaculatory ducts (seminal vesicle, vas deferens) postsurgical
procedure or post trauma on the genital organs.
9. Testicular cancer and cancer treatment. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Dorbalya (genera debility)
2. Mukhshosha
3. Panduta (pallor)
4. Shrama (easy fatigability)
5. Sadan (boydache) |
30 days, 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Semen analysis
2. CBC, RBS
3. Urine (Routine and microscopic) |
30 days, 45 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="1"
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
|
This study is comparative clinical trial of two species of Roscoea in oligozoospermia. This will be conducted on 60 male participants with oligozoospermia will be selected randomly from outdoor patients of Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar. Subject will be selected irrespective of their religion, occupation. Patient will be divided randomly into two groups each group will have 30 patients on the basis of inclusion and exclusion criteria. Follow up will be taken after 30th day and 45th day of treatment. |