| CTRI Number |
CTRI/2020/04/024452 [Registered on: 03/04/2020] Trial Registered Prospectively |
| Last Modified On: |
25/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study on the effect of Virechana Karma and Shwadamshtradi Ksheerapaka in Ksheenashukra (oligozoospermia) |
|
Scientific Title of Study
|
An open labelled clinical study on the effect of Virechana Karma followed by Shamana with Shwadamshtradi Ksheerapaka in the management of Ksheenashukra (oligozoospermia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirlep Kishorbhai Sojitra |
| Designation |
PG Scholar |
| Affiliation |
Government Akhandanand Ayurved Mahavidyalaya |
| Address |
OPD No. 11, Department of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad, Gujarat.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9265486374 |
| Fax |
|
| Email |
nksojitra11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Falgun Patel |
| Designation |
Associate professor |
| Affiliation |
Government Akhandanand Ayurved Mahavidyalaya |
| Address |
OPD No. 11, Department of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad, Gujarat.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9426404004 |
| Fax |
|
| Email |
vd.falgun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Falgun Patel |
| Designation |
Associate professor |
| Affiliation |
Government Akhandanand Ayurved Mahavidyalaya |
| Address |
OPD No. 11, Department of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad, Gujarat.
GUJARAT
380001
India |
| Phone |
9426404004 |
| Fax |
|
| Email |
vd.falgun@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of Government Akhandanand Ayurved Mahavidyalaya and Hospital, Near CNI Church, Bhadra, Ahmedabad, Gujarat-380001.
OPD and IPD of Government Smt. Maniben Ayurvedic Hospital, Asarwa, Ahmedabad, Gujarat-380010. |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurved Mahavidyalaya |
| Address |
OPD No. 11, Department of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad |
| 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 |
| Nirlep Sojitra |
Government Akhandanand Ayurved Mahavidyalaya |
OPD No. 11, Department of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad-380001.
Ahmadabad
GUJARAT |
9265486374
nksojitra11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E291||Testicular hypofunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
Single armed |
| Intervention |
Virechana Karma followed by Shwadamshtradi Ksheerapaka |
Shodhana: Virechana Karma
Poorvakarma:
Deepana and Pachana with Trikatu Choorna
Dose- 2 to 3g
Frequency- twice a day, as per Aatur-Agni
Duration- 3 to 5
days, till the appearance of Agnidipti Lakshana
Route of administration- orally
Aabhyantara Snehapana:
Goghrita
Dose- 20 to 40 ml starting
dose, in Vardhamana Krama as
per Atura-Koshtha and Agni
Time- Naishejeerne Anne
Frequency- once a day
Route of administration- orally
Duration- 3 to 7 days, depending upon the appearance of Samyak-Snigdha Lakshanas
Anupana- Ushnodaka
Diet- Light
diet (Drava Ushana
Anabhishyandi Pramanatah
Natisnighdha Asankeerna
Abhyanga and Swedana:
After completion of Abhyantara
Snehapana 1st, 2nd and 3rd
day during Vishrama Kala and 4th day Prior to Virechana Karma
Diet- Laghu, Sujara, Dravabhuyishtha diet, which should not increase Kapha will be given at the dinner of previous night of Virechana Karma.
Pradhanakarma:
Virechana Karma with Eranda Taila
Dose- 60 to 100ml as per Atura Koshtha
Time- at
Shleshmakalegate around 10am to 11am with
Ushna Godugdha
Route of administration- orally
Pashchatkarma:
Samsarjana Krama will be advised according to
shudhdhi for 3, 5 or 7 days
Shamana treatment:
Shwadamshtradi Ksheerapaka (Ashtanga Hridayokta) will be prepared as per Sharangdhara Samhita
Route of administration- orally
Dose- 80ml
Frequency- once a day before breakfast
Duration- 28 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Oligozoospermia i.e., Sperm count < 20 million/ml and patients with clinical presentation of Ksheenashukra (Oligozoospermia). |
|
| ExclusionCriteria |
| Details |
1. Virechana Karma Ayogya patients.
2. Patients of azoospermia (No spermatozoa in semen), aspermia (no ejaculation), polyzoospermia, asthenozoospermia, necrozoospermia and teratozoospermia.
3. Patients of various diseases like accessory sex gland infection, sexually transmitted diseases, varicocele, hydrocele, severe systemic diseases & having major psychiatric illness.
4. Patients having congenital diseases, genital abnormalities.
5. Patients having age less than 21 & more than 50 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Result will be assessed on the basis of relief in signs and symptoms of Ksheenashukra by specific scoring pattern |
9 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| By comparing semen analysis test before and after treatment |
9 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/04/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To study the effect of Virechana Karma and Shwadamshtradi Ksheerapaka in the management of Ksheenashukra (oligozoospermia). |