| CTRI Number |
CTRI/2026/03/105502 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of Amalaki Rasayana and Triphala Rasayana in men who have unusually thick semen |
|
Scientific Title of Study
|
An Open Label Randomized Comparative Clinical Study To Evaluate The Efficacy Of Amalaki Rasayana And Triphala Rasayana In Seminal Hyperviscosity Vis-À-Vis Kaphaja Shukra Dushti |
| 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 CHAVAN PRASHANT DILIP |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
Department of PG studies in Stree roga and Prasuti tantra, JSS Ayurveda Medical College and Hospital, 41 E lalithadripura road, Mysuru, Karnataka 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9595413869 |
| Fax |
|
| Email |
chavanprashant838@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIDYA NARAYAN |
| Designation |
HOD & Associate Professor |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
Department of PG studies in Stree roga and Prasuti tantra, JSS Ayurveda Medical College and Hospital, 41 E lalithadripura road, Mysuru, Karnataka 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9980760076 |
| Fax |
|
| Email |
vidya.dr@gmaill.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHAVAN PRASHANT DILIP |
| Designation |
Post Graduate Scholar |
| Affiliation |
|
| Address |
JSS Ayurveda Medical College and Hospital, 41 E lalithadripura road, Mysuru, Karnataka 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9595413869 |
| Fax |
|
| Email |
chavanprashant838@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR. CHAVAN PRASHANT DILIP |
| Address |
Department of PG studies in Stree roga and prasuti tantra, JSS Ayurveda Medical College and Hospital, 41 E Lalithradipura Road, Mysuru, Karnataka 570028 |
| Type of Sponsor |
Other [SELF] |
|
|
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 CHAVAN PRASHANT DILIP |
JSS Ayurveda Medical College And Hospital |
OPD 9,Department of PG Studies in Stree Roga and Prasuti tantra, 41 E lalithradipura Road, mysuru, Karnataka 570028
Mysore
KARNATAKA |
9595413869
chavanprashant838@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee- Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N469||Male infertility, unspecified. Ayurveda Condition: KAPADUSHTA-RETAS, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki Rasayana, Reference: Ch.Chi 1/2, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Rasayana, Reference: Ch.Chi.1/2, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 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 |
1) Subjects with symptoms of Kaphaja Shukra Dushti (Atipcchilata /hyper seminal viscosity).
2) Subjects willing to sign and give consent.
3) known case of primary and secondary infertility. |
|
| ExclusionCriteria |
| Details |
1) Known case of HTN and DM.
2) Diagnosed case of Varicocele (moderate to severe) and Cryptorchidism.
3) Known case of STD and Retroviral Diseases and TB.
4) Congenital obstructions of seminal ducts.
5) Diagnosed subjects of Chronic illness - Chronic Kidney Disease.
6) Known case of Genetic disorder - Youngs Syndrome and Klinefelter Syndrome and Kartageners syndrome and Celiac disease.
7) Diagnosed subjects of Cancer and ongoing chemotherapy. |
|
|
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 |
| Reduced in seminal viscocity |
31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/03/2026 |
| 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="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 an open label randomized comparative clinical trial conducted to evaluate the efficacy of Amalaki Rasayana and Triphala Rasayana in the management of seminal hyperviscosity, which is correlated with Kaphaja Shukra Dushti in Ayurveda. Male infertility contributes significantly to reproductive challenges, and seminal hyperviscosity is an important factor affecting sperm motility and fertility. In Ayurvedic classics, Kaphaja Shukra Dushti is characterized by excessive picchilata, which can be correlated with increased semen viscosity and delayed liquefaction time.
The study aims to assess the individual effects of Amalaki Rasayana and Triphala Rasayana on picchilata and to compare their therapeutic efficacy. A total of 40 male subjects aged 25 to 45 years fulfilling the inclusion criteria will be selected and randomly divided into two groups of 20 each. Group A will receive Amalaki Rasayana and Group B will receive Triphala Rasayana in a dose of 12 grams twice daily with milk after food for 30 days.
Assessment will be based on objective semen analysis parameters as per WHO 2021 guidelines, specifically liquefaction time greater than 60 minutes and semen viscosity more than 2 cm thread formation. Statistical analysis will be done using paired and unpaired t tests. Ethical clearance has been obtained and the study is conducted on human subjects only.
The research intends to provide clinical evidence for the role of Rasayana therapy in improving seminal parameters and managing Kaphaja Shukra Dushti associated with male infertility. |