| CTRI Number |
CTRI/2024/06/069118 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Kanchnaar Guggulu and Kanchnaar Guggulu with Prostate Massage Therapy in Vatashtheela(BPH) |
|
Scientific Title of Study
|
A Comparative Random Clinical Trial to compare efficacy of Kanchnaar Guggulu and Kanchnaar Guggulu with Prostate Massage Therapy in management of Vatashtheela w.s.r 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 |
Vishal Saini |
| Designation |
MS (Shalya Tantra) Scholar |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
PG Department of Shalya Tantra,Institute for Ayurved Studies And Research, Shri Krishna Ayush University, Sector-8, Umri road Kurukshetra ,136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9053480005 |
| Fax |
|
| Email |
Sainivishal1296@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal Saini |
| Designation |
MS (Shalya Tantra) Scholar |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
PG Department of Shalya Tantra,Institute for Ayurved Studies And Research, Shri Krishna Ayush University, Sector-8, Umri road Kurukshetra ,136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9053480005 |
| Fax |
|
| Email |
Sainivishal1296@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishal Saini |
| Designation |
MS (Shalya Tantra) Scholar |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
PG Department of Shalya Tantra,Institute for Ayurved Studies And Research, Shri Krishna Ayush University, Sector-8, Umri road Kurukshetra ,136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9053480005 |
| Fax |
|
| Email |
Sainivishal1296@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies And Research , Shri Krishna Ayush University |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research |
| Address |
Institute for Ayurved Studies And Research, Shri Krishna Ayush University, Sector-8, Umri road,Kurukshetra ,136118 |
| Type of Sponsor |
Government medical college |
|
|
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 Rajender Singh |
Institute For Ayurved Studies And Research |
Room No 104, PG Department of Shalya Tantra,Institute for Ayurved Studies And Research, Shri Krishna Ayush University, Sector-8, Umri road , Kurukshetra, 136118
Kurukshetra
HARYANA |
9416662761
drrajendersingh1346@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Krishna Ayush University |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kanchnaar Guggulu, Reference: Sharangdhar Madhyam khand Chapter 7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 22 Days, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: - | | 2 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: POORVA KARMA-
1. Written informed consent will be taken.
2. All vital parameters will be examined.
3. PC Enema will be given in left lateral position for complete evacuation of rectum.
4. After complete evacuation, patient will be instructed to lie on examination table in Lithotomy
position.
5. Preparation of local part by cleaning it by swab with gloved hands.
6. Part will be draped within a sterile cut sheet.
PARDHAN KARMA-
1.The lubricated glove(xylocaine jelly) figure will be inserted into the rectum.
2.Gently press on, or massage, the prostate.
3.The motion of the massaging finger will be from the outer edge of the lobe to the urethra, and
after thus massaging each lobe separately, the figure should be drawn from above downward, a
number of times, over the posterior urethra.[14-15]
4. The duration of massage 2 minutes or until milky secretion.
5. Massage might be uncomfortable for a few moments, but shouldn’t be painful.
11
6. This procedure will be performed alternate days in a week & this procedure will last upto 3
weeks.
PASCHAT KARMA-
1. Secretion will be cleaned with a sterile gauze soaked with povidine solution.
2. Patient will be advised to avoid forceful micturition.
3. Patient will be called for next sitting on 3rd day and before going for next sitting patient will be
assessed on due basis of assessment criteria.)
(1) Medicine Name: Kanchnaar Guggulu, Reference: Sharangdhar Madhyam khand Chapter 7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 22 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1.Patients with age above 40 years
2.Patients with International Prostate Symptoms Score(IPSS) under 7
3.Prostate Specific Antigen(PSA) under 6.5ng/ml
4.Post Void Residual Volume under 80ml
5.Urine Flow rate of under 15ml per sec for 2 voids
6.Chronic urinary retention
7.Willing and able to participate in the study for 66 days |
|
| ExclusionCriteria |
| Details |
1.Patient age below 40 and above 70
2.Patients having other urinary system pathology like severe UTI and calculai and urethral stricture
3.Patients suffering from malignanacy of urogenital system like CA of prostate
4.Patients having congenital deformity of urogenital tract
5.BPH with other obstructive uropathy
6.Serum Prostate Specific Antigen(PSA) high level
7.Acute retention of urine
8.Post Void Residual Volume greater than 80ml |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| International Prostate Symptom Score (IPSS) under 7 |
This score can be assessed at every sitting of procedure. In case of oral medicine this can be assessed on 22th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective criteria:
International prostate symptom score (IPSS)
Objective criteria:
Prostatomegaly
Post void residua volume of urine
Urine flow rate |
22days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/07/2026 |
| 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
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Vatashtheela is a disease of mutravaha strotas(urinary system), One among 12 types of mutragata(obstructive uropathy) disorder elaborated by Acharya Sushruta closely resembles to Benign Prostatic Hyperplasia(BPH) of modern science in its signs and symptoms. The Vatashtheela mutragata reflects the symptoms of urine retention, incomplete voiding, dribbling, hesitancy, dysuria, straining during urination etc. These are the features of lower urinary tract symptoms can be correlated with Benign Prostatic Hyperplasia in modern science. There have been many studies previously done in Ayurveda on Vatashtheela having special reference to BPH that are known to reduce the symptoms of the disease and improve the overall quality of life. But some patients do not respond the conservative treatment and surgery. That is why we planned this study for management of Vatashtheela w.s.r BPH. |