| CTRI Number |
CTRI/2022/06/043602 [Registered on: 30/06/2022] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Shukra vardhana effect of shivlingi beej powder in kshina shukra or Oligospermia |
|
Scientific Title of Study
|
Evaluation of shukra-vardhana effect of shivalingi beej(Bryonia laciniosa L.) in the management of kshina- shukra or oligospermia in adult Males : A randomised double arm double blinded placebo control clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himanshu Gautam |
| Designation |
PG Scholar |
| Affiliation |
All india institute of ayurveda |
| Address |
Department of dravyaguna All India Institute of Ayurveda (AIIA) Mathura Road Gautam Puri Sarita Vihar Delhi 110076
Department of dravyaguna All India Institute of Ayurveda (AIIA) Mathura Road Gautam Puri Sarita Vihar Delhi 110076
South
DELHI
110076
India |
| Phone |
8700769866 |
| Fax |
|
| Email |
hglovesu16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhargav Bhide |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of dravyaguna All India Institute of Ayurveda (AIIA) Mathura Road Gautam Puri Sarita Vihar Delhi 110076
South
DELHI
110076
India |
| Phone |
9372308023 |
| Fax |
|
| Email |
bhargava.183@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhargav Bhide |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of dravyaguna All India Institute of Ayurveda (AIIA) Mathura Road Gautam Puri Sarita Vihar Delhi 110076
South
DELHI
110076
India |
| Phone |
9372308023 |
| Fax |
|
| Email |
bhargava.183@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda Sarita Vihar,Gautam puri,New delhi |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr Himanshu gautam |
All india institute of ayurveda |
Opd no 1,2,3 ground floor, hospital block All india institute of ayurveda Department of dravya guna gautampuri, Sarita vihar, New Delhi 110076
South
DELHI |
8700769866
hglovesu16@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute Of Ayurveda |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: Kshina-shukra, (2) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: KLAIBYAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Starch powder, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shivalingi beej , Reference: Bhavprakash samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Sperm count below 15 million/ml
2. Patient with clinical presentation of kshina-shukra mentioned in classics i.e, Daurbalya, panduta,sadana shrama, klaibya, maithuna ashakti, chiraat praseka, shukra avisarga, medhra-vrishana vedanaa |
|
| ExclusionCriteria |
| Details |
1. Sperm count > 15million/ml
2. Patient of azoospermia and aspermia
3. patients suffering from varicocele, accessory sex gland infection, sexually transmitted diseases, severe systemic diseases etc. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the total sperm count more than 15 million per ml |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of kshina-shukra & other seminal parameters with crf |
45 days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/07/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Sexual health is an important aspect of every individual. Problems related to sexual health remain serious issue, particularly in young adults Infertility affects an estimated 15% of couples globally, amounting to 4KS million couples. The calculated global data shows that the percentage of infertility that is attributable to males ranged between 20.20%, and that the percentage of infertile men ranged from 2-5% to 12%, WHO estimate the overall prevalence of primary infertility in India is between 3,9 to 16.8 Indian states prevalence of infertility varies from state to suite such a 37 per cent in Uttar Pradesh, Himachal Pradesh and Maharashtra, so per cent in Andhra Pradesh and 15 per com in Kashmir and prevalence varies in same region across tribes and caste.
There is a regional variation in the prevalence of anospermia and oligozoospermia in the male partners of infertile couples from different reations of India. The prevalence of azospermia is extremely high in Kurnool and lodhpur (38.3% and 37.4%, respectively). There is also a regional variation in the prevalence of oligozoospermia (31%) in Kurnool
Ayurvedic classics have mentioned that the reproduction is the work of Shidra dhatu, kahina shikra is one of the eight types of Shukradhushti mentioned in the classics. Various drugs have been mentioned in Aurveda classics which act on Kshina-shukru. The drug Shivalingi is mentioned in raj nighantu as rasayani and sarv-siddhikara. The reference of Shivalingi found in In Bhavprakash Samhita for vandhyarva chikitsa as the seeds of Shivalingi are taken with milk which provide male progeny to pregnant mother. Shivalingi belongs to group of valuable drugs in the area of therapeutics of sterility and infertility disorders.
In modern medicines the conditions associated with Kshina-Shukra in ayurveda can be well matched with Oilgospermia. In this condition the sperm count comes below 15 milli/ml." According to ethnomedicinal review Shivalingi have aphrodisiac and -spermatogenic effect. The drug selected for this work is Shivalingi Beej (Bryonia laciniosa L.) and the drug is already evaluated for its Physicochemical, phytochemical study and pre-clinical study but the clinical study has not been conducted yet.
Considering this, present study has been undertaken to evaluate the Shukra vardhan Efecct of Shivalingi Beej
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