CTRI Number |
CTRI/2022/03/040713 [Registered on: 02/03/2022] Trial Registered Prospectively |
Last Modified On: |
18/10/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative clinical study of kokilaksha kshara and Ghana in the management of Urolithiasis |
Scientific Title of Study
|
A Comparative Pharmaceutico-Clinical study of Kshara kalpana and Ghana kalpana of Kokilaksha (Asteracantha longifolia Nees.)in the management of Mootrashmari(Urolithiasis) |
Trial Acronym |
Interventional, Randomised Controlled Trial |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Jayshri Babubhai Nakum |
Designation |
M.D. Scholar 1 st Year |
Affiliation |
Government Ayurved Collage Vadodara |
Address |
Upgraded department of Rasashashtra and Bhaishajya Kalpana, Government Ayurved College, Ajwa road, Dhanvantri marg, Panigate Vadodara Vadodara GUJARAT 390019 India |
Phone |
8469215443 |
Fax |
|
Email |
jeshnakum@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Bharti Umretia |
Designation |
Associate Professor |
Affiliation |
Government Ayurved Collage Vadodara |
Address |
Upgraded department of Rasashashtra and Bhaishajya Kalpana, Government Ayurved College, Ajwa road, Dhanvantri marg, Panigate Vadodara Upgraded department of Rasashashtra and Bhaishajya Kalpana, Government Ayurved College, Ajwa road, Dhanvantri marg, Panigate Vadodara Vadodara GUJARAT 390019 India |
Phone |
7600011944 |
Fax |
|
Email |
dr.bhartiumrethia@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kruti Vyas |
Designation |
Assistant Professor |
Affiliation |
Government Ayurved Collage Vadodara |
Address |
Upgraded department of Rasashashtra and Bhaishajya Kalpana, Government Ayurved College, Ajwa road, Dhanvantri marg, Panigate Vadodara Upgraded department of Rasashashtra and Bhaishajya Kalpana, Government Ayurved College, Ajwa road, Dhanvantri marg, Panigate Vadodara Vadodara GUJARAT 390019 India |
Phone |
9426393726 |
Fax |
|
Email |
vyas_krt@yahoo.co.in |
|
Source of Monetary or Material Support
|
Government Ayurved Collage and Hospital, Ajwa road, Dhanvantari Marg, Panigate, Vadodara- 390019 |
|
Primary Sponsor
|
Name |
Government Ayurved Hospital Vadodara |
Address |
Government Ayurved Hospital, Ajwa road, Dhanvantari Marg, Panigate, Vadodara 390019 |
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 Jayshri B Nakum |
Government Ayurved Hospital, Vadodara |
OPD and IPD, Government Ayurved Hospital, Vadodara
Department Vadodara GUJARAT |
8469215443
jeshnakum@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: MUTRASMARI, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kokilaksha Kshara, Reference: AFI PART 1/10, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: Kokilaksha Kshara is filled in Capsule | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kokilaksha Ghana, Reference: Shadangdhar Samhita Madhyam Khanda 8/1, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: Kokilaksha Ghana is Filled in Capsule |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients with all forms of Mootrashmari (Urolithiasis) with Classical sign and symptoms except Sukrashmari.
Patient having calculus size up to 10 mm.
A Known case of Mootrashmari (Urolithiasis) diagnosed by USG and or X-RAY.
|
|
ExclusionCriteria |
Details |
Patient having calculus size more than 10 mm with stone number more than 3 or Stag horn stone.
Pregnant women and lactating mother
Uncontrolled Diabetes Mellitus & Hypertension, cardiac Pathogenesis.
Any other serious systemic illness like AIDS, T.B., Malignancy etc
Patients with prostatic pathologies like BPH, carcinoma of prostate etc.
Patients with pathologies of KUB like Urethral stricture, Gross hydronephrosis, nephritis syndrome renal failure etc.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Change in the symptoms of Mootrashmari (Urolithiasis)
Naabhi-Basti-Sevani-Mehana-vedanaa (Pain at umbilical, bladder, perineal, penile region)
Mutra Vikirana (scattering urine)
Mutradhara sang (Interrupted flow)
Ati Avil mootrata (turbid urine)
Sarudhira mootra (urine with blood)
Sasiktam (with gravel) |
35 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Difference in classical symptoms in Clinical efficacy of Kokilaksha Kshara and Ghana in Mootrashmari (Urolithiasis) |
35 days |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
05/08/2022 |
Date of Study Completion (India) |
28/07/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="10" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical study was carried out after permission from institutional ethics committee clearance (GAV/VAD/IEC/68/2021, Dated 16/09/2021) and retrospectively registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2022/02/040713 [Registered on 02/03/2022]. Study type was interventional, open label randomized clinical trial. It explores with description of the aims and objectives, materials and methods, criteria of selection of the patients, general observations and effect of therapy. Also, a detailed description about the diagnostic criteria for Mootrashmari (Urolithiasis) along with the subjective and objective criteria for the assessment of results is stated here. Specialized scoring pattern for criteria for assessment was adopted were assessed in terms of percentage relief and statistical evaluation. Thereafter the observations and results are presented in tabular form followed by interpretation. The overall assessment of therapy was decided on the basis of scoring pattern. In this study, total 36 patients were selected and randomly divided into two groups, 18 in group A and 18 in group B respectively. Total 30 patients i.e. 15 in group A and 15 in group B completed the treatment with KK and KG respectively. Duration of treatment was 4 weeks along with follow up of 1 week. The observations were made on the parameters like age, sex, occupation, addiction etc. and cardinal symptoms like Naabhi-Basti-Sevani-Mehana-vedanaa, Mootradaha, Mootrakrichchha, Sarudhiramootra, Avilmootra etc., scrutinized, analyzed and recorded through a specially prepared proforma. The effect of all the drugs on signs and symptoms of disease, hematocrit values were recorded before and after treatment by adopting scoring pattern. Maximum numbers of patients (36.11%) were from the age group of 18-30 years, male (63.89%), married (80.56%) and Hindu (83.33%) by religion. Maximum patients were having Kapha Vata and Vata Pitta Prakriti (36.11%) each, Rajasika Manasa Prakriti (58.33%), Madhyama Satva (47.22%), Madhyama Samhanana (100%), Madhyama Pramana (100%), Madhyama Satmya (91.67%), Madhyama Vyayama Shakti (61.11%), Madyama Abhyavarana Shakti (83.33%) and Madhyama Koshtha (58.33%) were found in maximum patients. Amla Rasa (80.56%) Pradhana Ahara sevana was found in maximum of patients as etiological factor. Ahara dominant in Snigdha (66.67%) and Sheeta Guna (41.67%) was dominant majority of enrolled. Diwaswapa (83.33%) followed by Ushna Ahara (58.33%) and Asamsodhansheela (52.77%) was found maximum. Maximum patients developed the disease less than a year (52.78%) and a negative family history of Mootrashmari (urolithiasis) was found in (63.89%). Maximum patients showed symptoms of Mootrakrichchha (91.67%), Nabhi-Basti-Seveni-Mehana Vedana (88.89%) and Mootradaha (75%). In both group, highly significant result was found in Nabhi-Basti-Seveni-Mehana Vedana, Mootradaha, Mootrakrichchha, Stone size and Stone number while significant result was found in Sarudhiramootrata and Avilamootrata. In Group A was seen to provide better results on Sarudhiramootrata (100%), Avilamootrata (100%), Mootradaha (91.67%), Mootrakrichchhata (91.11%) and Nabhi-Basti-Seveni-Mehana Vedana (73.81%) where in group B shows better result on Sarudhiramootrata (100%), Mootrakrichchhata (100%), Avilamootrata (93.33%), Mootradaha (90.91%), Nabhi-Basti-Seveni-Mehana Vedana (66.67%) The variations observed in haematological parameters before and after treatment were statistically insignificant except neutrophil cell in in both group which statically highly significant (6.19% in group A and 5.84% in group B increase) which is within normal range and epithelial cell in urine statistically significant in group B (36.67% decrease). In group A total 23 kidney stones of different sizes were found in which 39.13% stones were expelled out, 47.83% stones were decreased in size and no change was observed in 8.69% stones whereas increase in stone size was observed in 4.35% of stones. In group B, total 16 kidney stones of different sizes found, in which 31.25% stones were expelled out, 43.75% stones were decreased in size and no change was observed in 6.25% stones whereas increase in stone size was observed in 18.75% of stones. In group A total 07 ureteric stone was found in which 28.57% of stones were expelled out whereas decrease in size was observed in 71.43% of stones. In group B total 05 ureteric stone was found in which all stones were expelled out (100%). Data reveals that group A and group B showed statistically insignificant difference in appearance of all parameter of Mootrashmari (Urolithiasis). In group A and group B, 6.67% and 26.67% of the patients showed complete remission, while marked improvement were seen in 40% and 33.33% of patients respectively. There is 53.33% patients showed moderate improvement in group A while 20% patients showed moderate improvement in group B. There is none patient was observed for unchanged result in both group. |