Role of ayurvedic drugs in Benign enlargement of prostate gland

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/08/006095
• Date of registration: 13-08-2015
• Prospective Registration: No
• Primary sponsor: IPGT RA
• Public title: Role of ayurvedic drugs in Benign enlargement of prostate gland
• Scientific title: A clinical study on kanchanar guggulu and matra basti of dhanyak gokshura ghrita in the management of mootraghata w.s.r. To BPH
• Date of first enrolment: 23-11-2010
• Target sample size: 30
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=6369
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr T S Dudhamal
• Affiliation: IPGT RA

• Name: Dr T S Dudhamal
• Affiliation: IPGT RA

Key inclusion & exclusion criteria

Inclusion criteria: Patients having signs and symptoms of mootraghata and BPH

Age above 50 years
Exclusion criteria: Uncontrolled diabetes mellitus hypertension

Heart diseases

Any type of malignancy

Age below 50 years

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients suffering from BPH

Intervention(s)

Intervention1: Matrabasti- dhanyak gokshura ghrita: 21 days
Intervention2: Kanchanar Guggulu 500 mg tds orally
: 21 days
Intervention3: combined therapy: rectal route Matrabasti of dhanyak gokshura ghrita od for 21 days
Kanchanar Guggulu 500 mg tds for 21 days
Intervention4: Group- A: kanchanar Guggulu 500 mg tds orally for 21 days: Kanchanar Guggulu A Ayurved Formulation 500 mg tds orally for 21 days
Intervention5: Group-B Dhanyaka Gokshura Ghrita 60 ml Basti (per rectal: Dhanyaka Gokshura Ghrita 60 ml Basti (per rectal administration) once daily in the morning for continue 21 days
Intervention6: Group- C: Dhanyaka Gokshura Ghrita 60 ml Basti (per rectal administration)and kanchanar Guggulu 500 mg tds orally for 21 days: Dhanyaka Gokshura Ghrita 60 ml Basti (per rectal administration) once daily in the morning for continue 21 days. Kanchanar Guggulu A Ayurved Formulation 500 mg tds orally for 21 days
Intervention7: Kanchanar Guggulu 500 mg tds orally: Kanchanar Guggulu 500 mg orally three times a day with luke warm water for 21 days will be given.
Control Intervention1: Group A kanchanar guggulu
Group B dhanyaka gokshura ghrita
Group C kanchanar guggulu and dhanyaka gokshura ghrita: Group A kanchanar guggulu
Group B Matrabasti with ghrita
Group C combined A & B
Control Intervention2: Matrabasti- dhanyak gokshura ghrita: Matrabasti with 60ml dhanyak gokshura ghrita through rectal route will be given once daily for 21 days.

Primary Outcome(s)

The improvement will be assessed on the basis of international prostate symptom score

Average urine flow rate

Prostate size

Post voidal residual urine volumeTimepoint:

3 weeks

Secondary Outcome(s)

The improvement will be assessed on the basis of international prostate symptom score

Average urine flow rate

Prostate size

Post voidal residual urine volume

average urine flow rateTimepoint: 3 weeks

Secondary ID(s)

NIL

Source(s) of Monetary Support

Source of Monetary or Material Support- Nil

Ethics review

Status: Not Applicable
Approval date:
Contact:

Institutional Ethics Commitee