| CTRI Number |
CTRI/2025/07/091495 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Medicated enema for low sperm count (Male infertility) |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SUKRALA BASTI IN KSHEENA SUKRA 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 ANAGHA KOMALANKUTTY |
| Designation |
PG SCHOLAR DEPARTMENT OF PANCHAKARMA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
3rd floor DEPARTMENT OF PANCHAKARMA ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIIRI MOODUBIDRE
DK DISTRICT
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9946128666 |
| Fax |
|
| Email |
anaghakomalan98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ROHINI PUROHIT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
3RD FLOOR DEPARTMENT OF PANCHAKARMA ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIIRI MOODUBIDRE
DK DISTRICT
KARNATAKA
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481845928 |
| Fax |
|
| Email |
dr.rohiniayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANAGHA KOMALANKUTTY |
| Designation |
PG SCHOLAR, DEPARTMENT OF PANCHAKARMA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIIRI MOODUBIDRE
DK DISTRICT
KARNATAKA
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9946128666 |
| Fax |
|
| Email |
anaghakomalan98@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIIRI MOODUBIDRE
D.K DISTRICT |
|
|
Primary Sponsor
|
| Name |
Dr ANAGHA KOMALANKUTTY |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIRI MOODUBIDRE
DK DISTRICT
KARNATAKA
574227 |
| 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 Anagha Komalankutty |
ALVAS AYURVEDA MEDICAL COLLEGE |
3RD FLOOR DEPARTMENT OF PANCHAKARMA ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIIRI, MOODUBIDRE,
D.K. DISTRICT
KARNATAKA
574227
Dakshina Kannada
KARNATAKA |
9946128666
anaghakomalan98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z00-Z99||Factors influencing health status and contact with health services. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Caraka Samhitha Sidhi sthana, Procedure details: The Sukrala Basti procedure is carried out over five days, with Niruha Basti administered in the mornings on Days 2 to 4 & Anuvasana (Matra) Basti in the afternoons on all five days. The preparation of Masha Atmaguptadi Basti involves mixing Madhu & Saindhava first, followed by the slow addition of Murchita Go Ghrita with continuous stirring. Then, Kalka made from Masha, Atmagupta, Godhuma, & Yava is added, & finally the corresponding Kwatha is incorporated to make a total of 485 ml. The mixture is filtered, warmed using a hot water bath, churned thoroughly, & stored in a sterile Basti Putaka, ensuring air is excluded & the contents are ready for administration.
For Niruha Basti, the patient undergoes prior bowel cleansing with Avipatti Churna, followed by local Abhyanga & Swedana. The Basti is administered with the patient in the left lateral position; the nozzle is gently inserted, & the medicine is introduced in one steady compression. Post-administration, the patient lies supine for one muhurta before evacuating. Anuvasana Basti is given in the afternoon post-lunch. After bowel & bladder evacuation, the patient lies on the left side, & Murchita Ghrita is administered using a lubricated catheter. The patient is advised to rest until natural evacuation occurs. Samyak Basti signs include proper elimination of mala, mutra, & vata, improved appetite, lightness in the body, & relief from disease symptoms.)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Patients of age group 25 to 50 years with total sperm concentration less than 15 million per ml.
Patients with duly written consent.
|
|
| ExclusionCriteria |
| Details |
Chronic uncontrolled Diabetes mellitus. Hypertension
Azoospermia and Aspermia
Diagnosed case of Genetic defect like Klinefelter syndrome
Bilateral Varicocele
Accessory sex gland infections
Diagnosed cases of STDs
H/O lower lumbar spinal injury
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Masha Atmaguptadi Basti in the management of Ksheena Sukra (Oligospermia) |
82 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the path of the Basti Dravya on administration in colon |
By Semen analysis following will be evaluated
1. Volume
2. Consistency
3. Sperm count
4. Motility rate
5. Morphology
6. Sperm density
7. Time of liquefaction
|
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| 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
|
Oligospermia, characterized by a low sperm count, is a significant cause of male infertility.
Ayurveda attributes this condition to Shukra Kshaya, primarily influenced by Vata and Pitta
doshas. Basti Karma, is considered effective in addressing Vata-related disorders and has been
postulated to enhance male reproductive health. Objective: This study aims to evaluate the efficacy of Masha Atmaguptadi Basti in improving
semen parameters in Ksheena Shukra (Oligospermia) and to assess the path of Basti Dravya
within the colon. Methods: A single-arm, open-label clinical trial will be conducted on 30 male patients
diagnosed with Oligospermia, recruited from Alva’s Ayurveda Medical College and Dhatree
Fertility Centre. The intervention involves the administration of Masha Atmaguptadi Basti over
a
specified treatment schedule. Semen parameters, including sperm count, motility,
morphology, and density, will be assessed pre- and post-treatment. Statistical analysis will be conducted using paired t-tests and
Wilcoxon signed-rank tests. Expected Outcome: The study hypothesizes a significant improvement in semen parameters
post-treatment, supporting the role of Masha Atmaguptadi Basti in managing Oligospermia. Conclusion: This study aims to contribute scientific evidence to the Ayurvedic management
of male infertility, potentially validating the efficacy of Basti therapy in enhancing sperm count
and overall reproductive health. |