| CTRI Number |
CTRI/2025/07/091986 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing Haritkyadi Kwatha and Gokshura Kwatha in patients with painful and burning urination (Cystitis). |
|
Scientific Title of Study
|
A Comparative Clinical Study t of Haritkyadi Kwatha and Gokshura Kwatha in the Management of Pittaja Mutrakruchha (Cystitis). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavan Suresh Ingle |
| Designation |
PG Resident |
| Affiliation |
Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner, Dist. Ahmadnagar |
| Address |
OPD No. 12, Shalya Tantra Department, Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner, Dist. Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9850477497 |
| Fax |
|
| Email |
pavaningale400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Tamhane |
| Designation |
Reader |
| Affiliation |
Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner, Dist. Ahmadnagar |
| Address |
OPD No. 12, Shalya Tantra Department, Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner, Dist. Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9764139607 |
| Fax |
|
| Email |
vtamhane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Tamhane |
| Designation |
Reader |
| Affiliation |
Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner, Dist. Ahmadnagar |
| Address |
OPD No. 12, Shalya Tantra Department, Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner, Dist. Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9764139607 |
| Fax |
|
| Email |
vtamhane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner, Dist. Ahmadnagar,State.Maharashtra, Country.India |
|
|
Primary Sponsor
|
| Name |
Pavan Suresh Ingle |
| Address |
Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner, Dist. Ahmadnagar,State.Maharashtra, Country.India |
| Type of Sponsor |
Other [Self] |
|
|
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 Pavan Suresh Ingle |
Ashvin Rural Ayurved College and Hospital |
OPD No. 12, Shalya Tantra Department, Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner, Dist. Ahmadnagar,State.Maharashtra, Country.India
Ahmadnagar
MAHARASHTRA |
9850477497
pavaningale400@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ashvin Rural Ayurved College & Hospital Manchi Hill, Ashvi Bk, Tal. Sangamner,Dist. Ahmednagar Pin-413714 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N309||Cystitis, unspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritkyadi kwatha , Reference: Bhavprakasha Of Bhavamishra Commentary by Dr. Bulusu Sitaram, Chaukhamba Orientalia, Varanasi, reprint edition 2017, Madhyam khanda Chapter 35 (Page no 394). Chakradatta of Shri Chakrapanidatta with Bhavartha Sandipani Hindi Commentary by Sh. Jagdishawar Prasad Tripathi, Chapter 32 (Page no 276) Chaukhambha Bharti Academy, 4th edition, 1976., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshura kwatha, Reference: Bhavamishra, bhavprakash poorvakhanda sloka 25th (Page no 239) editionvaranasi, chaukhamba orientalia,1988. Indian materia Nadkarni KM Dr, Indian Materia Medica vol 2.3rd edition(Page no 496). Bombay: Popular prakashan; 1976., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Mutrakruchha according to classical sign &
symptoms
H/o- Urinary Tract Infection not more than 7 days & didn’t taken any
antibiotics
Age between – 21-40 yrs
Either Sex
Dukhen Mutrapravritti
Mutra Daha
Pit varn mutra pravritti
Swalpa Muhurmuhu Mutra pravritti |
|
| ExclusionCriteria |
| Details |
1. Congenital Anomalies
2. K/C/O: BPH / Cancer / T.B / DM / HTN / STD / Impaired Renal Function and any other systemic disease
3. Renal Calculi, Pyelonephritis
4. Pregnant and Lactating Woman
5. Ashmarijanya, Shukrajanya, Purishaj and Shalyaj MutrakrMutrakruchha
6. Patient above 40 years and below 16 years
7. Any Comorbid condition |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of Haritkyadi Kwatha vs Gokshura Kwatha in reducing key symptoms of Pittaja Mutrakruchha (Cystitis) over a period of 28 days, assessed both subjectively and objectively.
Subjective parameters:
Burning micturition (Daha)
Painful urination (Ruja)
Frequency of micturition (Muhur Muhu Mutrata)
Discoloration of urine (Mutra Varna)
Objective parameters:
Pus cells count in urine
Epithelial cells
Urinary albumin
Urinary pH
RBCs in urine |
Weekly upto 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall symptom relief grading
Excellent greater than 75 percent relief
Marked 41 to 75 percent
Moderate 25 to 50 percent
Mild less than 25 percent
Safety and tolerability
Any adverse effect or withdrawal due to sideeffects
Comparative effectiveness to determine which formulation is more effective clinically and objectively |
Weekly upto 28 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/08/2025 |
| 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) |
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
|
To compare the effectiveness of Haritkyadi Kwatha and Gokshura Kwatha in managing Pittaja Mutrakruchha, a condition in Ayurveda comparable to cystitis (painful and burning urination). A total of 70 patients will be selected and randomly divided into two groups. Both formulations will be administered for 28 days, and outcomes will be assessed based on subjective symptoms and objective lab findings. The study intends to identify which kwatha offers better clinical improvement, contributing to more effective Ayurvedic management of urinary tract disorders. |