| CTRI Number |
CTRI/2025/02/080820 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Masha Paayasa formulation in Ksheena Shukra (less sperm count )with special reference to Oligospermia. |
|
Scientific Title of Study
|
A randomised Open -Label Controlled Clinical Study to Evaluate The Efficacy of Masya Paayasa in the Management of Ksheen Shukra with special Reference to Oligospermia |
| 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 Sunil Kamboj |
| Designation |
PG,Scholar , Dept. of Kayachikitsa |
| Affiliation |
Jammu Institute of Ayurveda and Research,Jammu |
| Address |
Room No 102, first floor , Dept. of Kayachikitsa ,JIAR ,Jammu,181123
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
09467021540 |
| Fax |
|
| Email |
kambojsunil58@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Mahajan |
| Designation |
Principal & Professor |
| Affiliation |
Jammu Institute of Ayurveda and Research,Jammu |
| Address |
Principal office & Room No 102, first floor , Dept. of Kayachikitsa ,JIAR ,Jammu,181123
Room No 102, first floor , Dept. of Kayachikitsa ,JIAR ,Jammu,181123
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9419119123 |
| Fax |
|
| Email |
drnitinmahajan1608@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Mahajan |
| Designation |
Principal & Professor |
| Affiliation |
Jammu Institute of Ayurveda and Research,Jammu |
| Address |
Principal office & Room No 102, first floor , Dept. of Kayachikitsa ,JIAR ,Jammu,181123
Room No 102, first floor , Dept. of Kayachikitsa ,JIAR ,Jammu,181123
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9419119123 |
| Fax |
|
| Email |
drnitinmahajan1608@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jammu Institution of Ayurveda and Research ,Jammu , India , Pincode 181123 |
|
|
Primary Sponsor
|
| Name |
Jammu Institution of Ayurveda and Research ,Jammu |
| Address |
Kot Bhalwal road Nardani,Jammu 181123 |
| Type of Sponsor |
Other [private Ayurveda 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 Sunil Kamboj |
Jammu Institution of Ayurveda and Research ,Jammu |
Room No 102, first floor , Dept. of Kayachikitsa ,JIAR ,Jammu,181123
Jammu
JAMMU & KASHMIR |
9467021540
kambojsunil58@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jammu Institution of Ayurveda and Research ,Jammu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E291||Testicular hypofunction. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Masha Paayasa , Reference: Chakarpani Chakradutt, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidaryadi Choorana, Reference: Siddh yog Sangraha by Vd. Yadavji Trikamji Rasayan & Vajikarana Aadhya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Inclusion criteria :-
1.Patients presenting with Pratyatma Lakshana of Kshina shukra ie. Klaibyam, Shukra avisarga, Maithuna ashakti etc.with semen samples suggestive of Oligospermia.
2. Sperm count less than 15 million / ml .
3.Male patients of age ranging from 25 to 45 years.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria :-
Age below 25 and above 45 years.
Patients with aspermia.
Genetic defects like Klinefelter syndrome.
Patients with diseases like Varicocele, Sexually transmitted diseases, and systemic diseases like DM, trauma, and any other chronic disorder etc. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters :
Symptoms of Ksheena shukra :
Klaibyam, Shukra avisarga, Maithuna ashakti etc.
Sexual health parameters - Desire, Erection, Ejaculation and Orgasm will be graded and assessed.
Objective parameters :
Semen analysis. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Seman Analysis |
Baseline ,15th ,30th and 45th day |
|
|
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)
|
01/03/2025 |
| 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="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
|
Infertility is defined as the failure of a couple to achieve a clinical pregnancy with regular unprotected sexual intercourse after 12 months or more . Low sperm count (oligospermia ) is one of the main causes of male infertility and is correlated with ksheena shukra . Dushti of shukravaha srotas , decreases the production of shukra dhatu leads to ksheena shukra. Ayurveda also explained in detail about infertility, its cause’s pathophysiology, and treatment under the umbrella of Vajikarana Aphrodisiac, one of the branches of Ayurveda. In Ayurveda various terms related to infertility are explained like Klaibya, Napunsaka, and Shanda which are indicative of impotency and the conditions like Shukra Dosha, Shukra Doshja Klaibya, Alparetasa, and Kshinaretasa can be related terms with infertility
NEED FOR STUDY : Infertility is a problem of global proportion affecting an average of 8%–12% of couples worldwide . Among the present data, also a male factor is solely liable for infertility in approximately 20% and contributory in another 30-40% of couples; intrinsically, a male factor is implicated in additional than 50% of couples seeking out for conception4 In present study one such formulation Masha paayasa (trial drug) has been mentioned by Acharaya Chakrapani in Chakradutt is taken to assess its efficacy in ksheenshukra w.s.r to Oligospermia and compared with Vidarayadi choorana (controlled drug) . |