| CTRI Number |
CTRI/2012/04/002586 [Registered on: 18/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
18/01/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulations in the patients of Prostate enlargement. |
|
Scientific Title of Study
|
Clinical Evaluation of Kanchanara Guggulu and Varuna Kwath Churna in the Management of Benign Prostate Hypertrophy (BPH). |
| Trial Acronym |
ACT- BPH-2010 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Support in terms of infrastructural facilities:
1. National Institute of Ayurveda (NIA), Jaipur.
2. Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola.
3. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan. |
|
|
Primary Sponsor
|
| Name |
Department of AYUSH Ministry of Health Family Welfare Government of India |
| Address |
Department of AYUSH, Ministry of Health & Family Welfare,
Government of India, IRCS Building, Red Cross Road, New
Delhi-110001 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M K Shringi DrSunil Kanodiya |
National Institute of Ayurveda (NIA), Jaipur |
Department of Shalyatantra, Amer Road, Madhav Vilas Palace, Jaipur-302002
Jaipur
RAJASTHAN |
09829194634
0141-2635709
drshringi1@yahoo.co.in |
| Dr Ramesh Arya Dr Javad Akther |
Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola |
Department of Shalya, Paprola, District Kangra-176115
Kangra
HIMACHAL PRADESH |
09418029271
01894242064
drramesharya@gmail.com |
| Dr P Hemanth Kumar Dr Vishwabharathi |
Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan |
Department of Shalya, Thannirohalla, B.M. Road, P.B. No.-64, Hassan-573201
Hassan
KARNATAKA |
9448156362
08172-256464
phk4u@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda (NIA), Jaipur |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola |
Approved |
| Institutional Ethics Committee, SDM College of Ayurveda, Hassan, Karnataka, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Benign Prostate Hypertrophy (BPH), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kanchanara Guggulu |
Dose – 1gm (2 Tablets) twice daily
Dosage form - Tablet of 500 mg
Route of Administration – oral
Time of Administration-Twice a day after food
Anupana-Lukewarm Water
Packing form- Bottle containg 600tablets
Duration of therapy-12 weeks |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Varuna Kwath Churna |
Dose – 25 gm twice daily
Dosage form – Kwath churna (to be consumed as a decoction)
Route of Administration – Oral
Time of Administration-Twice a day before food
Anupana-Lukewarm Water
Packing form-Plastic jar of 750 gm containing 30 sachets
Duration of therapy-12 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients with age between 45 and 70 years.
2. Patients with American Urology Association (AUA) symptom score > 8 and < 21
3. Rectal examination consistent with Benign Prostate Hypertrophy (BPH)
4. Prostate volume > 30cc
5. Prostate Specific Antigen (PSA) < 4 ng/ml
6. Urine flow rate of >5 to <15ml/sec for 2 voids
7. Willing and able to participate in the study for 16 weeks. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe Benign Prostate H (AUA score >21)
2. Patients currently using any other form of medical therapy for BPH/ Hair loss
3. Patients with H/O Transurethral Resection of Prostate (TURP)
4. Serum Prostate Specific Antigen (PSA) > 4 ng/ml
5. Chronic retention of urine (Post voidal urine volume > 150ml)
6. Refractory bacteriuria
7. Patients with persistent gross haematuria
8. Patients with evidence of malignancy
9. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
10. Patients with poorly controlled Hypertension ( >
11. Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 160 / 100 mm Hg)
12. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
13. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
14. Symptomatic patient with clinical evidence of Heart failure.
15. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
16. Alcoholics and/or drug abusers.
17. H/o hypersensitivity to any of the trial drugs or their ingredients.
18. Patients who have completed participation in any other clinical trial during the past six (06) months.
19. Any other condition which the Principal Investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Change in AUA symptom score during the period of 12 weeks.
• Change in Quality of Life (QOL) Index. |
AUA scoring is done at Baseline, at 14th day, at 28th day, at 42nd day, at 56th day, at 70th day, at 84th day andat the end of follow up at 16 weeks.
QOL score is done at Baseline, at 84th day and at the end of follow up period at 16 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Reduction in the post voidal residual volume of urine
• Improvement in Peak urine flow rate. |
At Baseline, at 84th day and at the end of follow up at 16 weeks. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
30/12/2010 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
To be published after the completion of the clinical trials in all the three centers. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country. Kanchanara Guggulu is a poly herbal preparation containing Kanchanara (Bauhinia variegata), Haritaki (Terminalia chebula), Bibhitaka (Terminalia bellerica), Amlaki (Phyllanthus emblica), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Varuna (Crataeva nurvala), Ela (Elettaria cardamomum), Tvak (Cinnamomum zeylanicum), Patra (Cinnamomum tamala) and Guggulu (Commiphora wightii).
Varuna Kwath Churna consists of dried stem bark of Crataeva nurvala. The present study is being undertaken in three post graduate Ayurveda colleges to scientifically study and validate the clinical efficacy and safety of Kanchanara Guggulu and Varuna Kwath Churna, the classical Ayurvedic formulations which have been in use since ages and found to be useful in treating Benign Prostate Hypertrophy and promoting the health. The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project. |