| CTRI Number |
CTRI/2025/05/086983 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of Eranda taila Matrabasti with Tamsulosin tablet in the management of vatashtheela (mutraghata) w.s.r to benign prostatic hyperplasia. |
|
Scientific Title of Study
|
Randomized controlled clinical study of Eranda taila Matrabasti with Tamsulosin tablet in the management of vatashtheela (mutraghata) w.s.r. to benign prostatic hyperplasia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran Uttam Sirsat |
| Designation |
PG scholer M S Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved College Babhulgaon Yeola |
| Address |
Matoshri Asarabai Darade Ayurved Hospital,Ground floor,OPD NO 04/05,Matoshri Asarabai Darade Ayurved college,SND Campus,Babhulgaon,Tal-Yeola,Dist-Nashik
Nil
Nashik
MAHARASHTRA
423401
India |
| Phone |
7385349279 |
| Fax |
|
| Email |
sirsat230@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj L Sonaje |
| Designation |
HOD and Professor,Department of Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved College Babhulgaon Yeola |
| Address |
Matoshri Asarabai Darade Ayurved Hospital,Ground floor,OPD NO 04/05,Matoshri Asarabai Darade Ayurved college,SND Campus,Babhulgaon,Tal-Yeola,Dist-Nashik
Nil
Nashik
MAHARASHTRA
423401
India |
| Phone |
9423932283 |
| Fax |
|
| Email |
manojsonaje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Uttam Sirsat |
| Designation |
PG scholer M S Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved College Babhulgaon Yeola |
| Address |
Matoshri Asarabai Darade Ayurved Hospital,Ground floor,OPD NO 04/05,Matoshri Asarabai Darade Ayurved college,SND Campus,Babhulgaon,Tal-Yeola,Dist-Nashik
Nil
Nashik
MAHARASHTRA
423401
India |
| Phone |
7385349279 |
| Fax |
|
| Email |
sirsat230@gmail.com |
|
|
Source of Monetary or Material Support
|
| Matoshri Asarabai Darade Ayurved College Affiliated With Matoshri Asarabai Darade Hospital,SND Campus,Babhulgaon,Yeola-423401 |
|
|
Primary Sponsor
|
| Name |
Matoshri Asarabai Darade Ayurved College,Babhulgaon,Yeola |
| Address |
Department Of shalyatantra,Ground Floor,OPD NO 04-05, Matoshri Asarabai Darade Ayurved College And Matoshri Asarabai Darade Hospital,SND Campus,Babhulgaon,Yeola-423401 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kiran Uttam Sirsat |
Matoshri Asarabai Darade Hospital,Babhulgaon,Yeola |
Department of shalyatantra,Ground floor,OPD no 04-05,Matoshri Asarabai Darade Ayurved college and Matoshri Asarabai Darade Hospital,SND Campus,Babhulgaon,Yeola 423401
Nashik
MAHARASHTRA |
07385349279
sirsat230@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Matoshri Asarabai Darade Ayurved College,Babhulgaon,Yeola |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Chakradatta chikitsa 33 shloka 1, Procedure details: Matrabasti with Eranda taila will be given for 7 days.60 ml of lukewarm Eranda taila loaded in an enema syringe. A sterile Red rubber catheter oleated with oil was attached to enema syringe.The red rubber catheter passed through the anus of the patient up to a length of 4 inches and the drug was administered.Matrabasti will be given once a day.)
(1) Medicine Name: Eranda Taila , Reference: Bhavprakash Tailvarga 6 shloka 22-23-24-25, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | TAB TAMSULOSIN | Tamsulosin is Alpha-1 adrenergic agent which inhibit smooth muscle contraction of prostate.They reduce bladder neck resistance so as to improve the urine flow.
Medicine Name:Tab Tamsulosin,
Reference:Smith and Tanaghos General Urology,19th Edition,Chapter No.38,Page No.597,
Route:oral,
Dosage Form:Tablet,
Dose:0.4 mg,
Frequency:Once a day (At Night),
Duration:7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1.Age group between 40 yrs to 70 yrs.
2.Classical sign and symptoms of Mutraghata (BPH).
3.USG of prostate suggestive of increased size and weight.
4.Significant post voidal urine of greater than 90CC upto 200 CC. |
|
| ExclusionCriteria |
| Details |
1.Age below 40 yrs and above 70 yrs.
2.Acute retention of urine.
3.Severe urinary calculi with significant obstructive uropathy.
5.Renal failure.
6.Systemic diseases like HIV, Hepatitis, T2DM.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The parameters will be noted down before and after treatment.
The patient will be diagnosed based on symptoms of Vatashteela (Mutraghata) explained in Ayurvdic and Modern texts.
1.Incomplete Emptying
2.Frequency
3.Intermittency
4.Urgency
5.Weak Stream
6.Straining
7.Nocturia |
1st,14th,21st,28th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
24/05/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acharya Sushruta The father of indian surgery has described 12 types of Mutraghata in uttartantra and also described the management of mutraghata which includes Basti,Uttarbasti,Virechan etc. Chikitsa. As ayurveda is an ancient science of medicine, had explained about the disease of urinary tract system i.e Mutraghata srotas under the topic of Mutrakricchara,Mutraghata, ashmari. Acharya Charaka has explained, an Apan Vayu is situated in the space between rectum and urinary bladder which produced a hard swelling like a stone,which is mobile,elevated ,and glandular . Which obstruct the passage of urine and feaces and produce symptoms like sanga. Prostate gland is the part of male reproductive system, it is of walnut size and weight about 1 ounce i.e 24 grams.Prostate is present below the urinary bladder and infront of rectum. it goes around the tube called urethra which carries urine from bladder out through penis. BPH is enlargement of medial lobe of prostate is responsible for obstruction of urethra. This lobe upwards into the bladder. Medicines like ALPHA BLOCKERS i.e Tamsulosin is effective in benign prostatic hyperplasia. Tamsulosin works by relaxing the muscle around the bladder and prostate gland so urine is passed more easily. This helps empty the bladder completely and reduces the need to pass urine frequently or urgently in BPH. |