| CTRI Number |
CTRI/2021/07/034716 [Registered on: 09/07/2021] Trial Registered Prospectively |
| Last Modified On: |
08/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
MANAGEMENT OF OLIGOZOOSPERMIA WITH AYURVEDIC INTERNAL MEDICINE AND THROUGH RECTAL ADMINISTRATION PROCEDURE |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF CHATUHA PRASRATIKA BASTI AND SATAVARI KSIRA PAKA IN THE MANEGMENT OF KSHINA SHUKRA WSR TO OLIGOZOOSPERMIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ARUN NK |
| Designation |
MD SCHOLAR |
| Affiliation |
DSRRAU Jodhpur |
| Address |
PG Department of Panchakarma
University College of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Karwar Nagur Road Jodhpur
PG Department of Panchakarma
University College of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Karwar Nagur Road Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9061180158 |
| Fax |
|
| Email |
arunnarayan.nk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor |
| Affiliation |
DSRRAU Jodhpur |
| Address |
PG Department of Panchakarma
University College of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Karwar Nagur Road Jodhpur
PG Department of Panchakarma
University College of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Karwar Nagur Road Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor |
| Affiliation |
DSRRAU Jodhpur |
| Address |
PG Department of Panchakarma
University College of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Karwar Nagur Road Jodhpur
PG Department of Panchakarma
University College of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Karwar Nagur Road Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Karwar Nagur road Jodhpur Pin 342037 |
| Type of Sponsor |
Government 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 ARUN NK |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University University Hospital of Ayurveda |
OPD No 6 PG Department of Panchakarma Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Karwar Nagur road Jodhpur Pin 342037
Jodhpur
RAJASTHAN |
9061180158
arunnarayan.nk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee UCA Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: KSHINA SHUKRA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CHATUHA PRASRATIKA BASTI AND SATAVARI KSIRA PAKA(INTERNAL MEDICINE) |
1.GROUP A CHATUHA PRASRATIKA BASTI 418 ML for 15 Days Duration.(RECTAL ADMINISTRATION)
2.GROUP B SATAVARI KSIRA PAKA 100 ML (50 ML MORNING AND 50 ML EVENING IN EMPTY STOMACH) FOR 30 DAYS DURATION.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1.Patient with classical symptoms of kshina shukra
2.Patient should not take any other medicine for kshina shukra
3.Patient who are basti yogya. |
|
| ExclusionCriteria |
| Details |
1.Sperm count above 20 million
2.Patients of azoospermia and aspermia
3.All congenital case of impotency
4.Necrospermia
5.Patient who had undergone surgical procedure for hydrocele varicocele etc
6.Patients suffering with STD, DM, TB, Typhoid ,Mallignancy
7.Any other conditions in which basthi is contraindicated. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE CRITERIA
THE SCORING SYSTEM DEVELOPED BY MEHRA AND SINGH(1995) WAS ADOPTED
OBJECTIVE CRITERIA
SIGNS OF SAMYAK BASTHI KARMA
SEMINAL ANALYSIS |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the comparative efficacy of the treatment in both groups WITH THE HELP OF SCORING SYSTEM DEVELOPED BY MEHRA AND SINGH (1995), SIGNS OF SAMYAK BASTHI KARMA AND SEMINAL ANALYSIS |
45 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
28/07/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Kshina Shukra is one among the Astavidha Shukra dushti, in which qualitative as well quantitative vitiation of Shukra dhatu occur. While describing the dushti associted with Shukra and Artava, Vagbhatacharya explained Kshina Shukra as a pathological condition caused by vitiated Vata and Pitta. Khsina Shukra somewhat resembles Oligozoospermia. Oligozoospermia also a disease of male reproductive system, in which there is quantitative reduction of the count of spermatozoa (<20million / ml). Kshina Shukra and Oligozoospermia conditions are not exactly same, but Oligozoospermia indicates quantitative vitiation of Shukra Dhatu (Kshina Shukra). In Allopathy various drugs like Testosterone, Clomiphene Citrate 25 mg orally etc. are being used to increase sperm count, However these drugs are expensive and producing several Adverse Effects like head-ache, blurred vision, stroke, seizure, shortness of breath, decreased testicular size, so we looking to alternative system especially Ayurveda and find out solution to increase sperm count motility and volume simultaneously. The study is open labelled parallel group trial to prove the efficacy of Chatuha Prasratika Basti and Satavari Kshira Paka (internally) in the management of Kshina Shukra w.s.r to Oligospermia. In one group, 25 patients will be administered with Chatuha Prasratika Basti for 15 days, next 25 patients will be administered with satavari kshira paka for 30 days. |