| CTRI Number |
CTRI/2018/04/013226 [Registered on: 12/04/2018] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AYURVEDIC TREATMENT OF PROSTATE (MOOTRAGHAT) |
|
Scientific Title of Study
|
A Comparative clinical study of Kanchnar Guggulu and Varuna Shigru
Guggulu along with Bala Taila Matra basti in the management of
Mootraghata w.s.r. to Benign Prostatic Hyperplasia |
| Trial Acronym |
BPH prostate |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Pravinbhai Chauhan |
| Designation |
PhD SCHOLAR |
| Affiliation |
IPGT RA |
| Address |
OPD NO 1 SHALYA TANTRA VIBHAG IPGT RA GUJARAT AYURVED UNIVERSITY JAMNAGAR
SHRI HARI 12 B RADHA KRISHNA PARK RELIANCE PETROL PUMP RAJKOT MAIN ROAD JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
8460320847 |
| Fax |
02882676856 |
| Email |
drpriyankachauhan24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T S Dudhamal |
| Designation |
Associate Professor |
| Affiliation |
IPGT RA |
| Address |
OPD NO 1 SHALYA TANTRA VIBHAG IPGT RA GUJARAT AYURVED UNIVERSITY JAMNAGAR
OPD NO 1 SHALYA TANTRA VIBHAG IPGT RA GUJARAT AYURVED UNIVERSITY JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
8849298620 |
| Fax |
02882676856 |
| Email |
dudhmal@ayurveduniversity.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Pravinbhai Chauhan |
| Designation |
PhD SCHOLAR |
| Affiliation |
IPGT RA |
| Address |
OPD NO 1 SHALYA TANTRA VIBHAG IPGT RA GUJARAT AYURVED UNIVERSITY JAMNAGAR
SHRI HARI 12 B RADHA KRISHNA PARK RELIANCE PETROL PUMP RAJKOT MAIN ROAD JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
8460320847 |
| Fax |
02882676856 |
| Email |
drpriyankachauhan24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalya tantra department IPGT RA hospital Gujarat Ayurved University Jamnagar Gujarat |
|
|
Primary Sponsor
|
| Name |
Institute for post graduation teaching and research in ayurveda |
| Address |
Institute for post graduation teaching and research in ayurveda opp city B divison police station jamnagar gujarat |
| 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 |
| PRIYANKA CHAUHAN |
SHALYA TANTRA DEPARTMENT IPGT RA |
OPD 1 SHALYA TANTRA DEPARTMENT IPGT RA GAU JAMNAGAR
Jamnagar
GUJARAT |
8460320847
02882676856
drpriyankachauhan24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, ipgt ra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N399||Disorder of urinary system, unspecified, Patients having signs and symptoms of mootraghat (BPH) as per Modern and Ayurveda considering Doshic variance of mootraghat. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kanchanar Guggulu |
In group A 1 gm Kanchanar Guggulu will be given trice a day along with balataila 60 ml matra basti once a day for 21 days |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Varuna shigru Guggulu |
In group B 1 gm Varuna shigru Guggulu will be given trice a day along with balataila 60 ml matra basti once a day for 21 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1. Increased Frequency /Urgency
2. Hesitancy
3. Decreased Urine Flow Rate / Weak Stream)
4. Acute/Chronic Urine Retention!
5. Scanty Micturation
6. Painful Micturation
7. Dysuria- Burning Micturation
8. Controlled cases of Diabetes and controlled
Hypertension patients will be included in
the study. |
|
| ExclusionCriteria |
| Details |
1. Patients of age below 40 years.
2. Patients of malignancy, congenital
deformities of urogenital tract or any
abdomino-pelvic pathology.
3. Systemic diseases like Uncontrolled
Hypertension and uncontrolled Diabetes,
uncontrolled TB, Paralysis, Parkinsonism
etc. will be excluded.
4. Known cases of HIV, VDRL, HbsAg will be
excluded.
5. Patients with heart disease like IHD, MI,
Angina, etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sign and Symptoms of BPH will reduce with treatment. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life |
2 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "81"
Final Enrollment numbers achieved (India)="81" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2018 |
| Date of Study Completion (India) |
29/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Published Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Methodology: In clinical study, patients of Mutraghata (BPH) were selected and divided
randomly by computerized randomization method into two groups. They were treated
with the formulations of Kanchnar Guggulu
and Bala Taila matra basti in
group-A and Varun-Shigru Guggulu and Bala
Tail Matra basti in group-B. The treatment was instituted for
the duration of 21 days. Out of 81 patients, 40 patients in group A and 41
patients in group B were completed therapy as well as follow up period. All the
patients were assessed as per subjective and objective criteria adopted during
the study & the findings were recorded in the clinical research performa.
Results: Statistically
highly significant (p<0.0001) result was noted in almost all the symptoms
i.e. increased frequency, nocturia, weak stream, incomplete voiding in the
patients of both groups.
In Group-A statically highly significant (p<0.0001)
result was observed in average urine flow rate and prostate size, and in post
voidal residual urine. In Group-B statistically highly significant
(p<0.0001) result was noted on size of enlarged prostate gland and in
average urine flow rate, while (p<0.05) significant changes were observed in
post voidal residual urine volume.
In case of laboratory investigations
specifically Sr. PSA (Ptostate specific antigen) in almost maximum patients
these values remained similar before & after the treatment so statistically
non significant (p>0.05) results found Conclusion: Finally study concluded that Kanchnar
Guggulu and Varuna Shigru Guggulu
orally along with Bala Taila Matra Basti is safe and found
equally effective in management of Mutraghata
(BPH).
|