| CTRI Number |
CTRI/2022/02/039994 [Registered on: 03/02/2022] Trial Registered Prospectively |
| Last Modified On: |
29/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to check the efficacy of Uttar Basti (administration of oil through urethra) and oral medicines in the management of Prostate Enlargement |
|
Scientific Title of Study
|
A clinical study to assess the efficacy of a treatment module including Shodhana followed by Shamana in the management of Benign Prostatic Hyperplasia (Mutraghata) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhijeet Dahiya |
| Designation |
Post Graduate Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No.725,Department of Panchakarma, Academic block,
All India Institute of Ayurveda,
Gautampuri, Sarita Vihar, South Delhi
South
DELHI
110076
India |
| Phone |
7042439876 |
| Fax |
|
| Email |
dr.abhijeetdahiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanth Dharmarajan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No.725,Department of Panchakarma, Academic block,
All India Institute of Ayurveda,
Gautampuri, Sarita Vihar, South Delhi
South
DELHI
110076
India |
| Phone |
9895174060 |
| Fax |
|
| Email |
drprasanthd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Anandaraman PV |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No.725,Department of Panchakarma, Academic block,
All India Institute of Ayurveda,
Gautampuri, Sarita Vihar, South Delhi
South
DELHI
110076
India |
| Phone |
9595130595 |
| Fax |
|
| Email |
dr.ananthramsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Sarita Vihar, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Mathura Road, Gautampuri, Sarita Vihar, New Delhi-110076 |
| 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 |
| Abhijeet Dahiya |
All India Institute of Ayurveda |
OPD No.-6, Hospital Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI |
7042439876
dr.abhijeetdahiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi Vati, Reference: Ca.Sa.Ci.15/96-97, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: upto 7 days or until Samyaka Pachana Lakshanas observed | | 2 | Intervention Arm | Procedure | - | avagAhasvedaH, अवगाहसà¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Ca.Sa.Su.14, Procedure details: Avagaha Swedana done as Poorvakarma of Basti for Sthanika Swedana)
| | 3 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® Pradhan Karma | (Procedure Reference: As.Hr.Su.19, Procedure details: Niruha Basti for 3 days with Varunadi Kwatha, Lajjalu Kalka, Vastyamayantaka Ghritam, Honey, Saindhava, followed by Uttara Basti for first 3 days with Varunadi Taila in a dose of 50 mL on Day 1, 55 mL on Day 2 and 60 mL on Day 3, followed by rest for 3 days, followed by Uttara Basti again for 3 days in the same increasing amount as above.)
| | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varunadi Kwatha, Reference: B.R., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: (2) Medicine Name: , Reference: Kanchnar Guggulu, Route: B.R., Dosage Form: Kwatha/ Kashaya, Dose: 32(2), Frequency: NA, Bhaishajya Kal: tds, Duration: Pragbhakta, anupAna/sahapAna: No, Additional Information: Lukewarm Water |
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients diagnosed with BPH Grade I, II or III.
2. Patients having classical signs and symptoms of Mutraghata.
3. Patients fit for Anulomana and Uttara Basti.
|
|
| ExclusionCriteria |
| Details |
1. Age below 40 years or above 80 years
2. Patients diagnosed with BPH Grade IV
3. Patients with malignancy, congenital deformities of urogenital tract or any pathology other than BPH
4. Patients with Diabetes Mellitus, Hypertension, Renal disorders or any other systemic disease
5. Patients unfit for Anulomana and Uttara Basti |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient is able to maintain normal urine flow |
0th Day, 21st Day, 41st Day, 60th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Prostate size |
0th Day, 60th Day |
| Reduction in Prostate Weight |
0th Day, 60th Day |
| Improvement in International Prostate Symptom Score (IPSS) |
0th Day, 21st Day, 41st Day, 60th Day |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
01/04/2022 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: BPH is a common condition that affects most of the adults as they grow older, and it greatly affects the quality of life. Modern treatment methods include oral treatments such as 5α-reductase inhibitors, α1 Adrenergic Antagonists (α1-Blockers), Muscarinic Receptor Antagonists (MRAs) which are known to have potential side effects. Surgical treatment methods such as Trans-Urethral Resection of Prostate (TURP) is also known to have common side effects such as TUR Syndrome etc. There are many studies and treatment methods described in Ayurvedic texts that are known to improve the condition with little or no side-effects. This study aims to define an effective treatment module for BPH management which will be used as a standard. OBJECTIVES: Primary: To assess the efficacy of a Treatment Module including Shodhana followed by Shamana in maintaining the normal urine flow in patients of Benign Prostatic Hyperplasia. Secondary: To reduce Prostate Size To reduce Prostate weight To improve IPSS in patients of BPH To validate a Module designed for management of BPH INVESTIGATIONS Prostate Specific Antigen (PSA) level before and after treatment Routine & Microscopic test of Urine Ultrasonography of Prostate Gland – before and after treatment Post Voidal Residual Volume – before and after treatment Other investigations such as Renal Function Test, FBS, PPBS CRITERIA FOR ASSESSMENT International Prostate Symptom Score (IPSS) Uroflowmetry – before and after treatment to assess the peak flow rate Post Voidal Residual Urine Volume Gradation of Prostate Size Gradation of Prostate Weight Prostate Specific Antigen (PSA) Levels
|