| CTRI Number |
CTRI/2025/02/081283 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of oligospermia |
|
Scientific Title of Study
|
Efficacy of Kaunchadi Granules in Ksheena Shukra W.S.R. to Oligospermia - An Open Labelled Randomized Standard Control Clinical Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kamal Kumar Sidar |
| Designation |
MS Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Prasutitantra evum Streeroga 5th floor institute building ITRA, Jamnagar Opp-B Division Police Station,Gurudwara Jamnagar Gujrat
Jamnagar GUJARAT 361008 India |
| Phone |
9300030178 |
| Fax |
|
| Email |
kamalsidar5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vd Grishma Solanki |
| Designation |
Lecturer |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Prasutitantra evum Streeroga 5th floor institute building ITRA, Jamnagar Opp-B Division Police Station,Gurudwara Jamnagar Gujrat
Jamnagar GUJARAT 361008 India |
| Phone |
9427753900 |
| Fax |
|
| Email |
grishmabams@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vd Grishma Solanki |
| Designation |
Lecturer |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Prasutitantra evum Streeroga 5th floor institute building ITRA, Jamnagar Opp-B Division Police Station,Gurudwara Jamnagar Gujrat
Jamnagar GUJARAT 361008 India |
| Phone |
9427753900 |
| Fax |
|
| Email |
grishmabams@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar Gujarat India pin 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Prasutitantra evum Streeroga 5th floor institute building ITRA, Jamnagar Opp-B Division Police Station,Gurudwara Jamnagar Gujrat |
| 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 |
| DrKamal Kumar Sidar |
Institute of Teaching and Research in Ayurveda |
O.P.D. No.6 PTSR OPD Institute of Teaching and Research in Ayurveda Jamnagar Jamnagar GUJARAT |
09300030178
kamalsidar5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Institute of Teaching and Research in Ayurveda, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | clomiphene citrate | clomiphene citrate is a drug of choice in male having low sperm count | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: kaunchadi Granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 12(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Patient willing to participate in study for 3 months with monthly follow up,Patient having sperm concentration less than 15 million/ml,Patient having sperm concentration along with decreased motility less than 50% & abnormal morphology and volume,Patient having normal thyroid function,Patient with or without clinical presentation of Ksheena Shukra like Daurbalya, Mukhashosha.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from primary or secondary Azoospermia or Aspermia,Patient having history of Male reproductive accessory gland infection, varicocele,Patient having history of previous scrotal or inguinal surgery,Patient having history of Testicular torsion, cryptorchidism,Penile trauma or Penis fracture (rupture of corpus cavernosum),Traumatic and non- traumatic spinal disorders,Patient Taking Cytotoxic drugs, alpha-blockers and spironolactone,Genetic disorders like Klinefelter syndrome,Patient taking treatment for major psychiatric illness,Patient known case of Hypertension (BP more than150/90 mmHg) and Diabetes mellitus (RBS more than 140 mg/dl), COPD, CKD, cardiac diseases, liver diseases, and Chronic Sinusitis,Patient known case of sexually transmitted diseases like Syphilis, Gonorrhea, HIV/AIDS.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To improvement in parameters of Semen Analysis |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Hormonal Assay.
To improvement in the quality of life & in score of IEEF Questionnaire |
90 days |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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)
|
10/03/2025 |
| 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
|
Kshinashukra is a burning problem of today’s era which not only affects the somatic part of body but also affect psychological health. Kshinashukra is variety of Shukradushti eventually leading to infertility and the same in biomedicine is referred as oligospermia. As per Ayurveda, oligospermia can be co-related with Kshinashukra. The prevalence of infertility in general population affects around one in eight couples of reproductive age, with a male factor being solely responsible in 20% and contributory in an additional 30% of cases. The drugs that are selected in this research are Kaunchadi Granules which are selected as trial drug. And tablet clomiphene citrate standard drug In Kshinashukra mainly involvement of Vata Dosha. Kaunchadi Choorna possesses Vrishya property.Guptaphala (Kauncha)and Gokshura have Madhura Rasa, Guru, Snigdha Guna, Seeta Veerya, Vrishya, Rasayana, Brimhana and Vattapittahara properties. Uchchata (Bhumyamalaki) has Madhura, Tikta, Kashaya Rasa, Laghu, Ruksha Guna, Sheeta Veerya and Balya. Milk has Madhura Rasa, Guru, Snigdha Guna, Sheeta Veerya, Madhura Vipaka, Rasayana, Brimhana, Vattapittahara and Sharkara is having properties of Madhura, Sheeta Veerya, Satmya, Shukravardhaka, Balya, Jeevaniya. All drugs have Vatapittahara property which helps in Samprapti Vighatana of Ksheena Shukra as it is Vatapitta predominant disease. However, Madhura Rasa, Snigdha, and Guru Guna increase the Shukra Dhatu qualitatively and quantitatively. It can increase the Testosterone by increasing the luteininzing hormone and the gonadotropin releasing hormone. Combination of drugs having adaptogenic, antioxidant, and aphrodisiac properties effectively have multifaceted sexual health benefits. The following investigations will be carried out before & after treatment to rule out other pathogenesis and assessment the status of subjects. Semen Analysis- (Physical examination, Microscopic examination, Other abnormalities), Hematological Examination - Hb%, TLC, DLC, ESR, Urine –Albumin, Sugar & microscopic, Bio-chemical investigation- RBS, Sr.Testosterone test and Serology Examination (HIV, HBsAg, HCV, VDRL),special laboratory test (FSH, LH, TSH) USG of Abdomen and Pelvis, Scrotum (Only BT). The participation in this research is entirely voluntary. In this present research work, 30 clinically diagnosed patient of Ksheenashukra (Oligospermia) will be registered and randomly divided into two groups. In Group A, Patients will be given Kaunchadi Granules (trial drug) every morning before breakfast, orally, 12 grams with milk twice a day for 90 days. In Group B, Clomiphene citrate tablet orally, 1 tablet (25 mg) with water once a day after food for 90 days. The patient will be withdrawn from study if patient complains of any adverse reaction or having any serious complications occur due to treatment will be referred to the higher centre. The patient will be withdrawn if patient desires to be discontinued treatment protocol. If any adverse drug reaction will be observed then it will be reported to the ADR cell (Pharmacovigilance cell of ITRA, Jamnagar). |