| CTRI Number |
CTRI/2025/03/083127 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Ayurvedic protocol in the management of male infertility |
|
Scientific Title of Study
|
An open label prospective clinical study of a
protocol-based Ayurvedic intervention in male infertility due to Oligospermia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Parameswaran Namboothiri |
| Designation |
Professor |
| Affiliation |
Amrita School Of Ayurveda, Amritapuri, Amrita vishwa vidyapeetham, India |
| Address |
Department of Panchakarma,
Room number 2 Amrita School Of Ayurveda, Clappana P.O, vallikkavu
Kollam
KERALA
690525
India |
| Phone |
09496096694 |
| Fax |
|
| Email |
nambu24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rajeswari PN |
| Designation |
Professor |
| Affiliation |
Amrita School Of Ayurveda, Amritapuri, Amrita vishwa vidyapeetham, India |
| Address |
Department of Shalyatantra, Room Number5, Amrita School Of Ayurveda, Clappana P.O, vallikkavu
Kollam
KERALA
690525
India |
| Phone |
08137070240 |
| Fax |
|
| Email |
drrajeshwariphd@gmail,com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kadambari PB |
| Designation |
Associate Professor |
| Affiliation |
Amrita School Of Ayurveda, Amritapuri, Amrita vishwa vidyapeetham, India |
| Address |
Department of Panchakarma, Room number 2, Amrita School Of Ayurveda, Clappana P.O, vallikkavu
Kollam
KERALA
690525
India |
| Phone |
09746004107 |
| Fax |
|
| Email |
kadambaripb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda
Clappana PO, Vallikkavu, Kollam 690525 |
|
|
Primary Sponsor
|
| Name |
Amrita School of Ayurveda |
| Address |
Clappana PO Vallikkavu 690525 |
| 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 Parameswaran Namboothiri |
Amrita School of Ayurveda |
Department of panchakarma Amrita School Of Ayurveda, Clappana P.O vallikkavu 690525
Kollam
KERALA |
9496096694
nambu24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical review committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAJAKLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pachanamritam Kashayam, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 60(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: Ushnajala), Additional Information: Kwatham with Ushnajala tid for 3 days(2) Medicine Name: chitrakadi vati, Reference: Bhaishajyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: with kwatham), Additional Information: Kwatham with Ushnajala tid for 3 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shuklashodhana gana lehyam, Reference: charaka samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: ksheera), Additional Information: 10 g Lehya twice daily after food eith milk(2) Medicine Name: vanari vatika, Reference: bhaishjya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Ksheera), Additional Information: 10 g Lehya twice daily after food eith milk | | 3 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Procedure Reference: charaka samhita, Procedure details: yoga basti with shukra shodhana gana kashaya & anuvasna basti with Maha narayana tailam )
(1) Medicine Name: chitrakadi vati, Reference: Bhaishajyaratnavali,, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: tds, Duration: 03 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1. Male subjects of Age group between 20-45 years
2. Sperm count less than 15million /ml.
3. Diagnosed cases of oligospermia
4. Subjects fit for Shodhana
5. Both fresh and treated cases will be included
|
|
| ExclusionCriteria |
| Details |
1. Varicocele with surgical indication
2. Previous reproductive organ Surgery
3. Sexually Transmitted Disease
4. Subjects categorized under Azoospermia.
5. Tuberculosis, HIV, AIDS, CA Testis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Volume
pH
Morphology
Liquefaction time
Sperm concentration
|
Base line 0th day
fourth week
eighth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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)
|
21/04/2025 |
| 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="2"
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 a problem of global proportions, affecting on an average 8-12% couples worldwide. Male infertility is considerably less complicated than Female infertility, but account for 30-40% of infertility. Except for some physical defects, low sperm count &poor sperm quality are responsible for male infertility in more than 90% cases. Oligozoospermia (sperm count < 20 million /ml semen),in about 30-40% the cause is unexplained, and in the rest of the cases critical illness, malnutrition, genetic abnormalities, pollution, side effects of some medicines, hormones and chemicals play a major role Oligozoospermic conditions can be correlated to that of kshina shukra concepts in ayurveda. The pathogenesis of kshina shukra is not mentioned in the classics, but it is stated that the vitiation of vata and pitta dosha is responsible for the manifestation of kshina shukra. Sub- normal parameters of shukra includes dravya,guna,karma features of shukra.The main line of treatment of kshina shukra has been suggested to be’ kshine shukrakarikriya’ and upachaya is the primary line of treatment. Drugs having vrishya, rasayana, and vajikarana properties can provide better results in the management of kshina shukra. A protocol incorporated with rookshana,snehana,swedana(poorvakarma) virechana and vasti with shukra shodhana gana kwatham, will be capable of relieving symptoms of Ksheena shukra. After shodhana karma, internal medication for Vajikarana, which can bring a markable change in Oligospermia cases. Shodhana chikitsa followed by Samana chikitsa will be adopted
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