| CTRI Number |
CTRI/2024/07/071342 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of BPH with vastyamayanthak ghrita as uttara vasti and rasa sindura orally |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of rasa sindura orally and uttarvasthi with vasthyamayantak ghritam in the management of vatashtila mutraghata with special reference to 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 Chenna Abhilash |
| Designation |
PG scholar |
| Affiliation |
DR BRKR GOVT AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
Room no. 6 department of Shalya tantra
Dr Brkr Ayurvedic college
Erragadda
Hyderabad
Pin 500038
Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
8801740489 |
| Fax |
|
| Email |
abhilashchenna007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Rajendra kumar |
| Designation |
Associate Professor department of shalya tantra |
| Affiliation |
DR BRKR GOVT AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
Room no. Six department of Shalya tantra Dr Brkr govt Ayurvedic medical college and hospital, erragadda, Hyderabad
Pin 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9866892281 |
| Fax |
|
| Email |
rkgoje@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Rajendra kumar |
| Designation |
Associate Professor department of shalya tantra |
| Affiliation |
DR BRKR GOVT AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
Room no.6 department of Shalya tantra
Dr Brkr govt Ayurvedic medical college and hospital, erragadda, Hyderabad
Pin 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9866892281 |
| Fax |
|
| Email |
rkgoje@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room no. Six Dr BRKR GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL
Erragadda Hyderabad
Pin 500038
Telangana state
India |
|
|
Primary Sponsor
|
| Name |
Dr BRKR GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no.six department of Shalya tantra
Dr BRKR government Ayurvedic medical college and hospital
erragadda, Hyderabad ,500038
Telangana state
India |
| 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 Chenna ABHILASH |
Room no. Six Dr Brkr govt Ayurvedic medical college and hospital |
Room no. 6, Dr Brkr govt Ayurvedic medical college and hospital, erragadda, Hyderabad, pin 500038 Telang state India
Hyderabad
TELANGANA |
8801740489
abhilashchenna007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of DR BRKR govt Ayurvedic medical college, Hyderabad |
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 | - | Uttaravasti | (Procedure Reference: Charaka Samhita, siddhi sthana, 9th chapter, 50th shloka, Procedure details: The patient taken in supine position & his phallus made erect and then lubricated with ghee. Then the enema nozzle with medicine is slowly introduced into his phallus and drug emptied into the bladder. The procedure is done for 3 consecutive days for 3 cycles with a gap of 12 days in between the cycles.))
(1) Medicine Name: VASTHYAMAYANTAK ghritam , Reference: Sahasra Yogam, ghrita prakarana, Route: Urethral, Dosage Form: Ghrita, Dose: 24(ml), Frequency: od, Duration: 45 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasa sindura, Reference: Rasa tarangini 6th chapter 1st shloka, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Kanji), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Subjects who are presented with symptoms of vatashtila and confirmed by digital rectal examination and ultrasound scan.
Patients with PSA value less than 10
|
|
| ExclusionCriteria |
| Details |
Patients with other cause of urinary tract symptoms like
Neurogenic bladder
Carcinoma prostate
Urethral stricture
Subjects with uncontrolled DM
subjects with chronic renal failure and cardiac problems |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Average change from base line of following parameters 1.PVR volume
2. Urinary symptoms like frequency, hesitancy, dribbling |
Patients are monitored at time points day0 day15, day30, day45 and day90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in prostate volume |
At day0, day15, day30, day45, & day90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a randomised clinical trial on efficacy of rasa sindura orally and uttravasthi with vasthyamayantak ghritam in the management of vatashtila (benign prostatic hyperplasia). Patients of age group 40-65 yrs who are diagnosed with vatashtila are taken for study. The duration of treatment is 45 days. Assessment will be done on every 15 days. Follow-up after 45 days of completion of treatment. |