| CTRI Number |
CTRI/2024/05/066978 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate The Effect Of Dashmooladi Kwath And Kalyanaka Kshara With Dashmooladi Kwath After Yog Basti In Patients Having Vatashtheela(Benign Prostatic Hyperplasia) |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Dashmooladi Kwath And Kalyanaka Kshara With Dashmooladi Kwath After Yog Basti In The Managment Of Vatashtheela (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.Rupesh Gangurde |
| Designation |
Pg Scholar |
| Affiliation |
All India Institute Of Ayurveda,New Delhi |
| Address |
Department Of Kayachikitsa,6 Th Floor,Academic Block,Block C,All India Institute Of Ayurveda,Sarita Vihar,New Delhi
South
DELHI
110076
India |
| Phone |
9637301931 |
| Fax |
|
| Email |
rupeshgangurde13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Jonah S |
| Designation |
Professor and Head Of Department,Department Of Kayachikitsa |
| Affiliation |
All India Institute Of Ayurveda,New Delhi |
| Address |
Department Of Kayachikitsa,6 Th Floor,Academic Block,Block C,All India Institute Of Ayurveda,Sarita Vihar,New Delhi
South
DELHI
110076
India |
| Phone |
8589805246 |
| Fax |
|
| Email |
jonahdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Rupesh Gangurde |
| Designation |
Pg Scholar |
| Affiliation |
All India Institute Of Ayurveda,New Delhi |
| Address |
Department Of Kayachikitsa,6 Th Floor,Academic Block,Block C,All India Institute Of Ayurveda,Sarita Vihar,New Delhi
South
DELHI
110076
India |
| Phone |
9637301931 |
| Fax |
|
| Email |
rupeshgangurde13@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda,New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute Of AyurvedaNew Delhi |
| Address |
All India Institute Of Ayurveda,Mathura Road,Gautam Puri,Sarita Vihar,New Delhi-110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 RUPESH GANGURDE |
ALL INDIA INSTITUTE OF AYURVEDA,NEW DELHI |
OPD OF KAYACHIKITSA DEPARTMENT,ALL INDIA INSTITUTE OF AYURVDA,GAUTAM PURI,SARITA VIHAR,NEW DELHI-110076
South
DELHI |
9637301931
rupeshgangurde13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,All India Institute Of Ayurveda,New Delhi |
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 | - | yoga-bastiH, योग-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: CHARAKA SAMHITA, Procedure details: BALA TAIL 80 ML ANUVASANA BASTI FOR 5 DAYS AND ERANDMOOLADI NIRUHA BASTI 500 ML FOR 3 DAYS IN YOGA BASTI KRAMA)
(1) Medicine Name: BALA TAIL, Reference: ASHTANG HRIDAYA, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: ERANDMOOLADI NIRUHA, Reference: ASHTANG HRIDAYA, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 3 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: DASHMOOLADI KWATH, Reference: BHAISHAJYARATNAWALI, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 42 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: KALYANAKA KSHARA, Reference: ASHTANG HRIDAYA, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: DASHMOOLADI KWATHA 100 ML), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1 Male Patients Having Age Between 40 TO 70 Years. 2 Patients Having Signs And Symptoms Of Vatashtheela(Bph). 3 Patients Diagnosed With Grade 1 2 Or 3.
4 Patients Having Psa Less Than Or Equal To 4. 5 Patients Fit For Niruha And Anuvasana Basti. |
|
| ExclusionCriteria |
| Details |
1 Patients Having Age Below 40 And Above 70.
2 Patients Diagnosed With Bph Grade 4.
3 Patients Having Psa Greater Than 4.
4 Patients With Malignancies And Congetinal Deformities Of Urogenital Tract.
5 Patients With Umcontrolled Diabetes And Hypertension.
6 Patients Unfit For Niruha And Anuvasana Basti. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement In Incomplete Emptying,Frequency,Intermittency,Urgency,Weak Stream,Straining,Nocturia In Patients Of Vatashtheela (BPH). |
Day 0,1 Week And 6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement In Quality Of Life Assesed With The Help Of International Prostate Symptom Score.
2.Changes In Post Voidal Residual Volume Of Urine And Prostate Size On Ultrasound. |
DAY 0,1 WEEK AND 6 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/05/2024 |
| 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 Yet Recruiting |
| 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
|
A. Primary Objectives
To evaluate the efficacy of Dadhmooladi
Kwath and Kalyanaka Kshara with Dashmooladi kwath after Yog Basti
in the management of Vatashtheela (BPH) in patients having age between
40 to 70 years by estimating the level of IPSS-International Prostate Symptom Score
(created by American Urology Association).
B. Secondary Objectives
·
To
determine the improvement in IPSS-International Prostate Symptom Score (AUA) in
patients of Vatashtheela (BPH).
·
To
evaluate reduction in Prostate Size.
·
To
evaluate reduction in Prostate weight.
·
To
validate a Module designed for management of Vatashtheela (BPH). |