| CTRI Number |
CTRI/2026/01/101138 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of MASHA CHOORANA” IN THE MANAGEMENT OF KLAIBYA WITH SPECIAL REFERENCE TO ERECTILE DYSFUNCTION”. |
|
Scientific Title of Study
|
A RANDOMIZED OPEN -LABEL CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ‘‘MASHA CHOORANA” IN THE MANAGEMENT OF KLAIBYA WITH SPECIAL REFERENCE TO ERECTILE DYSFUNCTION |
| 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 DHARMENDER |
| Designation |
PG SCHOLAR |
| Affiliation |
JAMMU INSTITUTE OF AYURVEDA AND RESARCH |
| Address |
P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR
P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9992466560 |
| Fax |
|
| Email |
Dharmendercsk123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NITIN MAHAJAN |
| Designation |
PROFESSOR & HOD |
| Affiliation |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
| Address |
P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR181123
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
97965257118 |
| Fax |
|
| Email |
drnitinmahajan1608@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NITIN MAHAJAN |
| Designation |
PROFESSOR & HOD |
| Affiliation |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
| Address |
P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR181123
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
97965257118 |
| Fax |
|
| Email |
drnitinmahajan1608@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI ,JAMMU,JAMMU AND KASHMIR 181123 INDIA
|
|
|
Primary Sponsor
|
| Name |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,JAMMU |
| Address |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI ,JAMMU,JAMMU AND KASHMIR 181123 INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 DHARMENDER |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
P.G. DEPARTMENT OF KAYACHIKITSA OPD and IPD of hospital,NARDNI, JAMMU, JAMMU AND KASHMIR- 181123
Jammu
JAMMU & KASHMIR |
9992466560
Dharmendercsk123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jammu Institute of Ayurveda and Research, Jammu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:U07-U07||Provisional assignment of new diseases of uncertain etiology or emergency use. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidarikanda choorana, Reference: Gadanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Masha Choorana, Reference: Gadanigraha in vajikarantantro Adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Male patients between the age group 25 to 50 years.
2. Patients having the symptoms of Klaibya.
3. Patients who are willing. |
|
| ExclusionCriteria |
| Details |
1. Patients with Psychiatric illness.
2. Patients with Sexually transmitted diseases.
3. Patients with Spinal injury and major pelvic surgeries.
4. Patients having systemic diseases ( DM , HTN, Tuberculosis ).
5. Patient with primary and secondary azoospermia, varicocele, trauma & torsion of testis, obstructive aspermia, vasectomy, STD, heart disease etc. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Harsh (Erection)
Sankalpa Pravan (Sexual Desire)
Vyavaysheelata (Frequency of Coitus)
Shrama (Post Act Exhaustion)
Ratrikriya (Performance Activity)
Veerya Skhalana ( Ejaculation)
Praharshan (Orgasm) |
Baseline,15th day,30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms |
Baseline |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2026 |
| 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 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
|
Erectile dysfunction is one among sexual dysfunction also known as Impotence, among the various phases of sexual response, the most essential is the achieving of normal erection with sufficient rigidity for penetrative intercourse, the absence of which ends into failure and dissatisfaction. This condition has been elaborately described as ‘Klaibya[2], in Ayurveda classics and ’Erectile dysfunction’ in contemporary texts.Although it would seem likely that it is somewhat difficult to assess the prevalence of erectile dysfunction (ED), it is claimed to affect as much as 10% of the male population. Above the age of 40, nearly 52% of men are affected. Despite this staggering incidence, few cases come to light.[3] The prevalence of ED across the world has a great deal of variation around 9-69% with a trend of a clear increase of this disorder at older ages. In all studies, ED has a rather high rate from 20% to 40% for the ages 60-69 years old, some increasing after the age of 65 years |