| CTRI Number |
CTRI/2023/03/051080 [Registered on: 27/03/2023] Trial Registered Prospectively |
| Last Modified On: |
24/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Marma Chikitsa on Vatashthila (Benign Prostate Hyperplaisa) |
|
Scientific Title of Study
|
To evaluate the effect of Marma Chikitsa in the management of Mutraghat with special reference to Vatashthila (Benign Prostate Hyperplasia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwarya Vijayvargiya |
| Designation |
MD Scholar |
| Affiliation |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurved College and Institute Bhopal M.P.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9981306425 |
| Fax |
|
| Email |
aishwaryavijaywargiya65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Gupta |
| Designation |
MD Ayu. Assistant Professor |
| Affiliation |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurved College and Institute Bhopal M.P.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425647011 |
| Fax |
|
| Email |
drpankaj35@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwarya Vijayvargiya |
| Designation |
MD Scholar |
| Affiliation |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurved College and Institute Bhopal M.P
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9981306425 |
| Fax |
|
| Email |
aishwaryavijaywargiya65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institue Bhopal M.P. |
|
|
Primary Sponsor
|
| Name |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institue Bhopal M.P. |
| Type of Sponsor |
Government funding agency |
|
|
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 Ashwarya Vijayvargiya |
Pandit Khushilal Sharma Government Autonomous College and Institute Bhopal MP |
Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurved College and Institute Bhopal M.P
Bhopal
MADHYA PRADESH |
9981306425
aishwaryavijaywargiya65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: VATASHTHILA, (2) ICD-10 Condition:N33||Bladder disorders in diseases classified elsewhere. Ayurveda Condition: VATASHTHILA (Benign Prostate Hyperplasia), |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: Marma Science and principals of Marma therepy - Dr S.k. JOSHI, Procedure details: Accprding to there anatomical location of indrabasti and Gulf Marma sthan , every marma sthan will be stimulated 15-18 times on an average single sitting .
A steady and moderate pressure will be applied slowly and gently .
Pressure will be increased gradually depending upon patients strenght.
)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo control | 15 patients of this group will be given placebo control ( Rosted Wheat flour capsules) Dose - 2 caspules (each 250mg) BD after meal.
Anupan - Sukhoshn jal
Duration -2 months
follow up - 1month after completion of treatment |
|
|
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Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. The Patients with IPSS International prostatic Symptom Score (0-7) Mild and ( 8-19 )Moderate.
2. Patient willing to be registered for study with written consent.
3. Patient having BMI less than 30 kg/m2.
|
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 45 years and above 85 years.
2. Patient having BMI more than 30kg/m2.
3 Patient with IPSS International Prostatic Symptom score (19-35)Severe.
4 Patient with any severe illness Like Tuberculosis, Cardiac Disease ,Liver disease or Any Malignancy.
5. Patient having severe psychiatric illness.
6. Patients not willing for written consent
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of study, scholar will be able to evaluate Effect of Marma Chikitsa in the Management of Mutraghat with special reference to Vatashthila (Benign Prostate Hyperplasia)1 Incomplete emptying 2 Frequency 3 Intermittency 4 Urgency5 Weak Stream
6 Straining7 Nocturia
|
It is expected that at the end of 3 months, scholar will be able to evaluate Effect of Marma Chikitsa in the Management of Mutraghat with special reference to Vatashthila (Benign Prostate Hyperplasia)1 Incomplete emptying 2 Frequency 3 Intermittency 4 Urgency5 Weak Stream
6 Straining7 Nocturia
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of study, scholar will be able to evaluate Effect of Marma Chikitsa in the Management of Mutraghat with special reference to Vatashthila (Benign Prostate Hyperplasia) |
It is expected that at the end of 3 months, scholar will be able to evaluate Effect of Marma Chikitsa in the Management of Mutraghat with special reference to Vatashthila (Benign Prostate Hyperplasia) |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/04/2023 |
| 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 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)?
Response - NO
|
|
Brief Summary
|
IN THIS STUDY DETAILS OF MUTRAGHAT WITH SPECIAL REFRENCE TO VATASHTHILA AND THE MODERN REFERENCE OF BENIGN PROSTATE HYPERPLASIA WILL BE DONE FROM LITERATURE. WE WILL EVALUATE THE EFFECT OF MARMA CHIKITSA IN THE MANAGEMENT OF MUTRAGHAT WITH SPECIAL REFRENCE TO VATASHTHILA (BPH). The initial assessment included the International Prostatic Symptoms Score (IPSS) The International Prostate Symptom Score (I-PSS) is based on the answers to seven Questions concerning urinary symptoms.. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the Particular symptom. The answers are assigned points from 0 to 5. Thetotal score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The questions refer to the following urinary symptoms: Questions included in I-PSS score.. 1 Incomplete emptying 2 Frequency 3 Intermittency 4 Urgency5 Weak Stream 6 Straining7 Nocturia
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