| CTRI Number |
CTRI/2025/04/083780 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
To study efficacy of joshanda(Darchini, Saleekha, Saad, Qaranfal, Bisbasa) in the patients of Benign Prostatic Hyperplasia |
|
Scientific Title of Study
|
Clinical study to validate the safety and efficacy of joshanda ( Darchini, Saleekha, Saad, Bisbasa and Qaranfal) in the management of Warm-e-Ghudda-e-Mazi (Benign Prostatic Hyperplasia): An open label, randomized, standard control study . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shameem Ahmad Rather |
| Designation |
HOD and Professor, Department of moalijat |
| Affiliation |
Regional Research Institute of Unani Medicine Srinagar |
| Address |
Department of Moalijat,RRIUM Naseem Bagh Campus, University of
Kashmir, Srinagar, Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.sr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shameem Ahmad Rather |
| Designation |
HOD and Professor, Department of moalijat |
| Affiliation |
Regional Research Institute of Unani Medicine Srinagar |
| Address |
Department of Moalijat,RRIUM Naseem Bagh Campus, University of
Kashmir, Srinagar, Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.sr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farhaan Yaqoob |
| Designation |
PG Scholar Moalijat |
| Affiliation |
Regional Research Institute of Unani Medicine Srinagar |
| Address |
Department of Moalijat,RRIUM Naseem Bagh Campus, University of
Kashmir, Srinagar, Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006155472 |
| Fax |
|
| Email |
farhanyaqoob66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central council for research in unani medicine (CCRUM),D block Janakpuri,New dehli ,India, 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine New Delhi |
| Address |
Regional Research Institute of Unani Medicine (RRIUM),University of
Kashmir,Naseem bagh campus,Srinagar, 190006 |
| Type of Sponsor |
Research institution |
|
|
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 Shameem Ahmed Rather |
Regional Research Institute of Unani Medicine |
Moalijat OPD-1, Ground
floor, Department of
Moalijat, RRIUM,
Naseembagh Campus
University of Kashmir
Hazratbal Srinagar
JAMMU & KASHMIR
Srinagar
JAMMU & KASHMIR
Srinagar
JAMMU & KASHMIR |
7889584083
shameem.rather.SR@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RRIUM srinaga |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Decoction (joshanda)
|
All the herbs ( Darchini , Saleekha , Saad , Qaranfal and Bisbasa) will be given to the patient in crude form with the total dosage of 24 gms . Then patient will prepare decoction by soaking herbs in 500 ml of water and then simmer it for 20 to 30 minutes on the gas or stove. And then strain the remaining liquid 250 ml from the residue. The resulting liquid will be the decoction.And will be taken orally before breakfast once a day for 3 months |
| Comparator Agent |
Tab . Tamsulosin |
Tab . Tamsulosin 0.4mg will be given once orally bed time for 3 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Male |
| Details |
A diagnosed case of BPH (Warm-e- Ghudda-e- Mazi) that meets the following criteria;
1. Males in the age range of 40 -79 years.
2. Patient expressing concerns about hesitation, frequency and urgency of urination.
3. Patients with a serum PSA level of 4 to 10
ng/ml.
|
|
| ExclusionCriteria |
| Details |
1. Patients under the age of 40 and older than 79 years.
2. Patients that are mentally disturbed.
3. Refusal to provide consents by patients.
4. Known case of Hypertension, CHD, CKD, liver disease and uncontrolled diabetes.
5. PSA levels over 10ng/ml, suspecting carcinoma
6. Complete urine retention. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum PSA
USG (prostate specific) |
Serum PSA on day 0 and day 91
USG (prostate specific) on day 0 and day 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in IPSS (international prostate symptom score) Arbitary scale
Improvement in QOL ( Quality of life) |
IPSS on Day 0 and Day 91
BPH related Arbitary scale at Day 0, 15th ,30th ,45th, 60th ,75th, 91st
QOL at Day 0 and 91 |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
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
|
Benign prostate hyperplasia (BPH) is the expansion of prostate gland in elderly men,
which can cause partial or complete bladder outlet obstruction producing them to have
lower urinary tract symptoms.
It is a common urological disease among older men. The age specific prevalence of BPH has
been estimated to be 8% in the fourth decade of life, 50% in the sixth decade of life and 80%
in the ninth decade of life . Since BPH itself is not lethal, urine flow obstruction is its
most significant outcome that has a negative impact on person’s ability to engage in physical
activity and their mental health. Dribbling of urine, frequent micturation especially at night,
a hesitant, interrupted or weak stream of urine, sense of incomplete bladder emptying are
some symptoms of BPH. BPH has been described under the headings of Warm-e- Ghudda-e-Mazi,Salaa-e--Ghudda-e-Mazi ,and Warm-e- Unaq-e- Masaana in Unani system of medicine. However, symptomatic BPH treatment is typically found in our classical writings under
several categories such as Ehtabas-e-baul , Taqteer-ul -baul and Usr-e-baul . The
symptoms and the size of the prostate can be reduced with medical therapy, however
allopathic medicine does have number of negative effects. Since ancient times, Unani
physicians have used secure herbal treatments to treat the BPH symptoms. However, there
are not enough credible scientific studies to backup this practice. Scientific confirmation of
these safe medications is urgently required. The purpose of the current study is to find a safe
and effective treatment for BPH by examining how polyherbal Unani formulation affects BPH patients. |