| CTRI Number |
CTRI/2024/08/072783 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Two Ayurvedic Treatments for Benign Prostatic Hyperplasia (BPH) in Men: Sahacharadi Oil vs. Bala Oil Therapy. |
|
Scientific Title of Study
|
Comparative evalutaion of Efficacy of Sahacharadi Tail Uttarbasti with Bala Tail Matarbasti in the Management of Vatashthila (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 |
Dr Sheetal Asutkar |
| Designation |
Professor and Head of department |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre |
| Address |
Room no 16, OPD, Department of Shalya Tantra, Mahatma Gandhi Ayurveda college Hospital and Research centre, DMIHER, Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Professor and Head of department |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre |
| Address |
Room no 16, OPD, Department of Shalya Tantra, Mahatma Gandhi Ayurveda college Hospital and Research centre, DMIHER, Salod Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Professor and Head of department |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre |
| Address |
Room no 16, OPD, Department of Shalya Tantra, Mahatma Gandhi Ayurveda college Hospital and Research centre, DMIHER, Salod Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College and Hospital Salod Wardha 442001 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurveda College and Hospital |
| Address |
Mahatma Gandhi Ayurveda College and Hospital Salod Wardha
442001 Maharashtra |
| 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 |
| Dr Sheetal Asutkar |
Mahatma Gandhi Ayurveda College Hospital and Research Centre |
Room No.- 13,
Department of Shalya Tantra, Mahatma Gandhi Ayurveda College Hospital and Research Centre, Salod Hirapur Wardha.
Wardha
MAHARASHTRA |
9766811974
sheetalasutkar16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUE OF HIGHER EDUCATION AND RESEARCH |
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 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Ambikadutta SK, editor. Sushruta Samhita of Acharya Sushruta, Uttara Tantra. Ver 27-28., Ch. 58. Varanasi: Chaukhambha Sanskrita Sansthan; 2003. p. 540, Procedure details: UNDER ALL ASEPTIC PRECAUTIONS AND STERILE CONDITION 60 ML OF sAHACHARADI TAIL UTTARVASTI WITH THE HELP OF 60 ML SYRINGE SLOWLY ONCE DAILY FOR 21 DAYS.)
(1) Medicine Name: CAP KUSHMANDADI YOGA, Reference: Shastri P.Durgadatta, Sharangdhar Samhita,Chaukhamba Surbharathi Prakashan, Reprint2014,New Delhi,Chapter-7 P no.-103, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushruta Samhita, Uttar Tantra, Mutraghata Pratishedhahyaya, 58/27. Reprint. Vaidya Yadavaji Trikamji Aacharya., editor. Varanasi: Chaukhamba Surbhaarati Prakashana; 2008. p. 789., Procedure details: UNDER ALL ASEPTIC PRECAUTIONS AND STERILE CONDITION 60 ML OF BALA TAIL MATRA VASTI WITH THE HELP OF 60 ML SYRINGE SLOWLY ONCE DAILY FOR 21 DAYS.
)
(1) Medicine Name: KUSHMANDADI YOGA, Reference: Shastri P.Durgadatta, Sharangdhar Samhita,Chaukhamba Surbharathi Prakashan, Reprint2014,New Delhi,Chapter-7 P no.-103, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients willing with Written informed Consent for will be taken.
2. Patient in the age group between 35-85years.
3. Patients with having mild to moderate BPH having Prostate size up to 50gm (Grade 3) will be included after screening.
4. Patients who are indicated for Matrabasti
|
|
| ExclusionCriteria |
| Details |
1.Patients of Grade 4 BPH i.e. above (50gm).
2.Patient suffering from Systemic disorders like uncontrolled Diabetes mellitus, Tuberculosis, Hypertension.
3.Urethral Stricture
4.Functional BOO (Bladder Outflow Obstruction) due to neurological conditions like CVA, Tabes Dorsalis, Parkinsonism, Disseminated Sclerosis, Loss of Neuro vesicle co-ordination, Syringomyelia, Alzheimers disease.
5.Carcinoma of Prostate
6.Diverticulum of the bladder
7.Trigone Hyperplasia
8.Disability due to old age and serious systemic illness
9.Acute and chronic Retention of urine
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A decrease in International Prostate System (I-PSS) Score |
1st follow up day 21
2nd follow up day 28
3rd follow up day 35 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| an increase in quality of lie due to urinary symptoms |
1st follow up day 21
2nd follow up day 28
3rd follow up day 35 |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
28/08/2024 |
| 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
|
The study aims to compare the efficacy of Sahacharadi Tail Uttarbasti and Bala Tail Matrabasti in managing Vatashthila (Benign Prostatic Hyperplasia, BPH). Primary objectives include evaluating the efficacy of both treatments individually and comparing their effectiveness. Secondary objectives involve the pharmaceutical preparation and analysis of the medicated oils. Data will be sourced from classical texts and patients selected from the Shalyatantra OPD & IPD at Mahatma Gandhi Ayurved College, Wardha. The study design is a randomized clinical trial involving 40 patients divided into two groups: Group A receiving Sahacharadi Tail Uttarvasti and Group B receiving Bala Tail Matrabasti, both supplemented with Cap Kushmandadi Yoga. Patients will be assessed on days 0, 7, 14, and 21, with follow-ups on days 21, 28, and 35. Inclusion criteria include patients aged 35-85 with mild to moderate BPH, while exclusion criteria cover patients with severe BPH, systemic disorders, and other specific conditions. The assessment will utilize both subjective (AUA-SI or I-PSS) and objective (USG) criteria. Data analysis will involve the Wilcoxon Rank Sum Test, and the study’s results, discussion, and conclusions will be drawn post-analysis. |