| CTRI Number |
CTRI/2025/07/090087 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the effect of Varunadi Kwath in elderly men with urinary problems due to enlarged prostate (BPH)
|
|
Scientific Title of Study
|
Evaluation of Efficacy of Varunadi Kwatha in the Management of Vatasthila 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 |
Vimal Kumar |
| Designation |
PG Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road |
| Address |
OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja Bulandshahar GT Road
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7906662522 |
| Fax |
|
| Email |
vimalkumardixit32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun Anil |
| Designation |
Associate Professor |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road |
| Address |
OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja,Bulandshahar GT Road
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
6360340886 |
| Fax |
|
| Email |
dr.arjunanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Anil |
| Designation |
Associate Professor |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road |
| Address |
OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja,Bulandshahar GT Road
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
6360340886 |
| Fax |
|
| Email |
dr.arjunanil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya And PLRD Hospital Khurja Bulandshahar Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya |
| Address |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road Bulandshahar Uttar Pradesh 203131 |
| 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 |
| Vimal Kumar |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road |
OPD Number 5 Department of Shalya Tantra Vaidya Yagya
Dutt Sharma Ayurved
Mahavidhalaya Dharpa
Khurja Bulandshahar GT Road
Bulandshahar
UTTAR PRADESH |
7906662522
vimalkumardixit32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar Uttar Pradesh |
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: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varunadi Kwath, Reference: Chakradatta Ashmari Adhyaya 29, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Grasantara bhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Yavakshara and Ushna Jala), Additional Information: -Administered in Group A to evaluate efficacy in BPH (Vatasthila) patients. Drug administered orally in a dose of 50 ml twice daily after meals for 45 days. Follow-up was done on day 15, 30, and 45. The formulation was prepared as per classical reference with raw drugs. |
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1.Patients age between 40 to 70 years
2.USG suggestive of BPH
3.Patients not willing for surgery
4.Post-voidal residual urine upto 100 ml
5.Frequency of urine more then 2 times and less than 5 times at night
|
|
| ExclusionCriteria |
| Details |
1.Patitents age below 40 or above 70 years
2.Cases of BPH in which surgery is indicated
3.Patients diagnosed with carcinoma of the prostate
4.Patients having acute urinary retention
5.Cases with Severe UTI
6.Patients with urethral stricture
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change of Frequency of Micturition , Change in Nocturia episodes,change in IPSS Score |
Baseline (Day 0), 15th Day, 30th Day, and 45th Day (End of Treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess cost-effectiveness of Varuna Kwatha.
To evaluate reduction in symptom recurrence. |
Day 22-Faster recovery and well-being
Day 45- Cost-effectiveness and Symptom recurrence |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
04/07/2025 |
| 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="0"
Months="9"
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
|
Vatasthila has symptoms similar to Benign Prostatic Hyperplasia (BPH), which is a non-malignant enlargement of the prostate gland commonly seen in elderly males. BPH includes obstructive and irritative urinary symptoms like urinary retention, nocturia, urgency, and incomplete bladder evacuation. In Ayurveda, Vatasthila is described under Mutraghata. Modern treatments have side effects and surgical complications. Varunadi Kwatha, mentioned in Chakradatta Ashmari Adhyaya, has Kaphahara, Lekhana, and Mutrala properties. It acts through Vatanulomana, Shothahara, and Deepana effects. A randomized, single-blind, controlled clinical trial will be conducted on 40 patients for 45 days. Follow-ups will be on Day 15, 30, and 45. Assessment will be based on IPSS score, urinary frequency, urgency, nocturia, prostate size, and residual urine volume. |