| CTRI Number |
CTRI/2022/05/042424 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
07/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
clinical study for the efficacy of Vajroli Mudra with Ashvagandha Churna in Premature ejaculation |
|
Scientific Title of Study
|
Prospective Randomized Comparative clinical study for the efficacy of Vajroli Mudra with Ashvagandha Churna in Premature ejaculation |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suhas Sakhare |
| Designation |
Asst. Professor , Dept of Swasthvritta |
| Affiliation |
Guru Ravidas Ayurved University, Hoshiarpur , Punjab |
| Address |
department of Swasthvritta,
Saraswati Ayurved Hospital & medical college, Gharuan, Mohali ,Punjab.
Hoshiarpur
PUNJAB
140413
India |
| Phone |
08668387814 |
| Fax |
|
| Email |
suhassakhare7020@gmail.con |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja R Sharma |
| Designation |
Professor in Dept of Swasthvritta |
| Affiliation |
Shri Dhanwantry Ayurved College and Hospital, Chandigarh |
| Address |
department of Swasthvritta and yoga,Shri Dhanwantry Ayurved college & Hospital ,Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9041584513 |
| Fax |
|
| Email |
neerjasharma2966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhas Sakhare |
| Designation |
Asst. Professor , Dept of Swasthvritta |
| Affiliation |
Guru Ravidas Ayurved University, Hoshiarpur , Punjab |
| Address |
Department of Swasthvritta , Sarswati Ayurved Hsopital & Medical college, Gharuan, Mohali, Punjab
Hoshiarpur
PUNJAB
140413
India |
| Phone |
8668387814 |
| Fax |
|
| Email |
suhassakhare7020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarswati Ayurved Hospital & Medical College, Gharuan, Mohali,Punjab |
|
|
Primary Sponsor
|
| Name |
Dr Suhas Sakhare |
| Address |
Department of Swasthvritta, Sarswati Ayurved Hospital & Medical College, Gharuan, Mohali,Punjab |
| Type of Sponsor |
Other [self] |
|
|
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 Suhas Sakhare |
Sarswati Ayurved Hospital & Medical College, Gharuan |
National Highway 95, Ludhiana - Chandigarh State Hwy, Sahibzada Ajit Singh Nagar,gharuan,Mohali, Punjab 140413
Hoshiarpur
PUNJAB |
8668387814
suhassakhare7020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GURU RAVIDAS AYURVED UNIVERSITY HOSHIARPUR PUNJAB |
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:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: VATADUSHTA-RETAS, (2) ICD-10 Condition:N531||Ejaculatory dysfunction. Ayurveda Condition: VATADUSHTA-RETAS, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | vajroli mudra | (Procedure Reference: hathyogpradipika, Procedure details: for 3 months ,early morning for 10 min)
(1) Medicine Name: Ashvgandha, Reference: dravyagauna, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Duration: 3 Months |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Ejaculation prior to ten penile thrusts.
2. Ejaculation before, on or within one minute of sexual act after penetration.
3. Unable to satisfy partner in at least 50% of the coital incidences.
4. Unable to delay ejaculation till the person wishes it.
5. The problem should be persistent or recurrent and cause marked distress or interpersonal difficulties
|
|
| ExclusionCriteria |
| Details |
1. Factors that effect the duration of the excitement phase of sexual act such as novelty of the partner or situation and recent frequency of sexual act were taken into account.
2. The problem should not be a due exclusively to the direct effect of a substance (E.g. withdrawal of opioids)
3. Persons having very short post ejaculatory refractory period were excluded.
4. Major psychiatric illness
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
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Primary Outcome
|
| Outcome |
TimePoints |
| WE ARE GOING TO SEE THE CHANGES IN Hamilton’s Anxiety Rating Scale. |
time duration for this outcome in 3 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| we are going to see changes in serum testosterone level |
time duration for secondary outcome in 3 months |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/05/2022 |
| 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="0"
Months="1"
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
|
Ayurveda mentions Ahara, Nidra and Brahmacharya as the Tripods of life. [i]Sex is a basic instinct, but sexual behaviour is a learned ability. Dharma, Artha, Kama and Moksha are among the four Purusharthas, objectives of life mentioned in Ayurveda. The achievement of each of these is the basic need of every individual. The concept of Kama reveals that the recreational aspects like pleasure are equally important to its procreation aspects. The present lifestyle additionally impacts unsatisfied inquisitiveness lead them to various misconceptions and sexual dysfunctions like premature education. Premature ejaculation (P.E.), also known as rapid ejaculation, rapid climax, premature climax or early ejaculation. It is characterized by a lack of voluntary control over ejaculation. The term "premature ejaculation" is not well defined in medical circles and is sometimes considered to be more of a marketing tool than a medical condition.[ii] Testosterone (T) is hormone that controls ejaculation. For sexual activity to take place, synchronized transmission of sexual desire is needed. It arises from the brain and is transmitted to the periphery, resulting in penile erection, necessary for sexual intercourse. T has long been considered as an essential hormone in regulating this process, acting both at central and peripheral levels. only one study has reported the higher serum levels of free testosterone (FT) in PE patients[iii]. In Ayurveda the problem is discussed under Shukragata vata. Functional approximation Shukra, Manah And Vata are quite evident in Ayurvedic principles. The problem is caused by a vitiated Vata causing hyper stimulation of Manah and lack of control over ejaculation.[iv] Ayurveda compares Shukradhatu (semen) to purified butter. Just as purified butter melts in the presence of heat, semen loses its consistency when there is Pitta (fire) aggravation in the body. Aggravated Pitta travels into the channels carrying semen, causing semen to decrease in constency, and thus it gets ejaculated before sufficient erection. Biological and psychological factors can also play a role in causing premature ejaculation. Vajikarana (aphrodisiac therapy) is one of the eight branches of Ayurveda that deals with the preservation and amplification of the sexual potency of a healthy man and conception of healthy progeny as well as management of defective semen, disturbed sexual potency, and spermatogenesis, along with treatment of seminal-related disorders in man.[v] Ashwagandha is most Potent Vajikara drug.[vi] The present status emphasizes the necessity of imparting adequate knowledge and Ayurvedic management of sexual dysfunctions like premature ejaculation. In the present study a protocol was made to manage premature ejaculation by using Vajroli Mudra and Ashvgandha Churna |