Comparative clinical study of kokilaksha kshara and Ghana in the management of Urolithiasis
- Conditions
- Urinary calculus, unspecified. Ayurveda Condition: MUTRASMARI,
- Registration Number
- CTRI/2022/03/040713
- Lead Sponsor
- Government Ayurved Hospital Vadodara
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the symptoms of Mootrashmari (Urolithiasis) 35 days Naabhi-Basti-Sevani-Mehana-vedanaa (Pain at umbilical, bladder, perineal, penile region) 35 days Mutra Vikirana (scattering urine) 35 days Ati Avil mootrata (turbid urine) 35 days Sasiktam (with gravel) 35 days Mutradhara sang (Interrupted flow) 35 days Sarudhira mootra (urine with blood) 35 days
- Secondary Outcome Measures
Name Time Method Difference in classical symptoms in Clinical efficacy of Kokilaksha Kshara and Ghana in Mootrashmari (Urolithiasis) 35 days
Trial Locations
- Locations (1)
Government Ayurved Hospital, Vadodara
🇮🇳Vadodara, GUJARAT, India
Government Ayurved Hospital, Vadodara🇮🇳Vadodara, GUJARAT, IndiaDr Jayshri B NakumPrincipal investigator8469215443jeshnakum@gmail.com