| CTRI Number |
CTRI/2022/08/044956 [Registered on: 26/08/2022] Trial Registered Prospectively |
| Last Modified On: |
29/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study conducted to see the effect of Kanchanar guggulu and Amrutadi kwath in prostate enlargment. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical study to evaluate the effect of Kanchanara Guggulu with Amrutadi Kwatha in the management of Mutraghata with special reference to Benign Prostate Hyperplasia (BPH) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ainapure Kiran Ravindra |
| Designation |
MS (Scholar) Shalyatantra |
| Affiliation |
BVVS Ayurved Medical College and Hospital |
| Address |
BVVS Ayurved Medical College And Hospital
Bagalkot
BVVS Ayurved Medical College And Hospital
Bagalkot
KARNATAKA
587101
India |
| Phone |
9172819633 |
| Fax |
|
| Email |
kiranainapure76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh S Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital |
| Address |
BVVS Ayurved Medical College And Hospital
BVVS Ayurved Medical College And Hospital
Bagalkot
KARNATAKA
587101
India |
| Phone |
9886664541 |
| Fax |
|
| Email |
dryogesh6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR M M Salimath |
| Designation |
Principal And Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital |
| Address |
BVVS Ayurved Medical College And Hospital
BVVS Ayurved Medical College And Hospital
Bagalkot
KARNATAKA
587101
India |
| Phone |
9845010950 |
| Fax |
|
| Email |
dr_mahantesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurved Medical College And Hospital Bagalkot 587101
|
|
|
Primary Sponsor
|
| Name |
BVVS Ayurved Medical College and Hospital |
| Address |
BVVS Ayurved Medical College
And Hospital Bagalkot 587101
|
| Type of Sponsor |
Private medical college |
|
|
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 Ainapure Kiran Ravindra |
BVVS Ayurved Medical College and Hospital |
BVVS Ayurved Medical College and Hospital
Bagalkot
KARNATAKA |
9172819633
kiranainapure76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N400||Benign prostatic hyperplasia without lower 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: Amrutadi kwatha, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kanchara Guggulu, Reference: Sharangadhara Samhita, Route: Oral, Dosage Form: Guggulu , Dose: 1500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
The cases with features mentioned in International prostate symptoms scoring namely Frequency of urination Intermittency of urination
Urgency
Straining
Weak stream of urine
Nocturia
Incomplete emptying of bladder
Cases of BPH confirmed by USG within mild and moderate grade 30 – 50 grams
|
|
| ExclusionCriteria |
| Details |
Ca Prostate and other metastatic and neoplastic conditions
Neurological disease of urinary system, Stricture Urethra
Patients with Infectious diseases like RVD, HBsAg.
Exceeding more than 100ml volume with weight more than 100gm Patient having more than 10cm width x 8cm height x4cm thickness
According to I-PPS chart 20-35 scoring is severe are exclude
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of kanchanar guggulu in the management of mutraghata with special reference to BPH
|
21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Kanchanara Guggulu and Amrutadi Kwatha in the management of Mutraghata with special reference to BPH |
21th days |
|
|
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)
|
30/08/2022 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Nil. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Mutraghata is a disease of Mutravaha Srothas in which Avarodha i.e. obstruction to the flow of urine is the main feature. There are many conditions in Mutravaha Srothas where obstruction can be present, one such condition is Vatashtila explained under the heading of Mutraghata by Acharya Sushruta.1 In Vatashtila, Prakupita Apana Vayu located between Shakrunmarg and Basti, produces a glandular like swelling that causes Mutrasanga, Atopa, Vithsanga, Mutraavrodha, these features can be correlated with features of Benign Prostate Hyperplasia.2 It is a nodular hyperplasia of prostate gland due to formation of one or more nodules, which leads to hesitancy, dysuria, frequency, urgency, haematuria, retention of urine.3 Benign Prostate Hyperplasia occurs in men over 50 years of age, by the age of 60 years 50 % of men have histological evidence of B.P.H. and 15 % have significant lower urinary tract symptoms, therefore there is an intense and persistent requirement to find a simple, safe and economical treatment for B.P.H.4 Kanchanara Guggulu is mentioned in Sharangdhara Samhita in the management of Granthi5 and Amrutadi Kwatha is explained in Bhaishajyaratnavali in the management of Vatadi Mutrakricha6. In Yogratnakara, Mutraghata Chikitsa Adhaya in the context of Samanya Kriya, it is mentioned that bheshaja which are used in the management of Ashamari and Mutrakricha can be used in the Mutraghata Chikista7. Amrutadi Kwatha ingredients having properties of Medhohara and Vata Kaphahara, Mutral, Rasayana in Karma, where Kanchanara Guggulu’s ingredients having properties of Vata Kapha Shamaka, Basti Shodhaka ,Granthighna and Mutral.8 By taking the above references the study is undertaken to evaluate the combined effect of Amrutadi Kwatha and Kanchanara Guggulu in the management of Mutraghata with special reference to Benign Prostate Hyperplasia. |