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Clinical Trials/CTRI/2022/06/043410
CTRI/2022/06/043410CompletedNot Applicable

Efficacy Of Triphaladi Kwatha And Mustadi Kwatha In The Management Of Dyslipidemia- An Open Labeled Randomized Clinico- Comparative Study

Government Akhandanand Ayurveda College And Hospital1 site in 1 country30 target enrollmentStarted: June 22, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Primary:-Results will be assesed on the basis of Lipid Profile Reports.

Study Overview

Brief Summary

·       Inthis study, total 30 patients were registered and all patients had completedtreatment along with follow- up.

·     In this study, maximum 50 % i.e., 15 patients werebelonging to the age group of 45-65 years followed by 36.66 % i.e., 11patients were belonging to 31-45 yearsage group,13.33 % to 18- 30 years of age group.

·     In this study 50 % patients were females and rest 50 % patientswere males among the registered 30 patientsof Dyslipidemia.

·     In this study maximum numbers of patientsi.e., 93.33 % were from Hindu community, whereas 6.66 % patients were from Muslim community.

·     In the present study maximum numbers of patientsi.e., 90 % were from Urban Locality, whereas 10 % patients were from rurallocality.

·     In the present study 96.66 % of patients were married,whereas 3.33 % patients were unmarried.

·      In the present study maximum 56.66 % patients werehaving education till graduation, 20 % were having education HSC, 23.33 % werehaving education till Post Graduate.

·     In the present study socio-economically 36.66 % patients were from upper middleclass, 63.33 % were lower middle class.

·      In the present study 43.33 % patients were housewife, 43.33% were doingservice, 13.33 % were having business.

·   In the present study 25 patients(83.34 %) had Sedentary habit, 15 patients (50%)had menopause aggravating factors.

·   In the present study 11patients (36.66 %) had positive previous drug history, 19 (63.33%) had negative drug history.

·   In the present study 7 patients(23.33 %) had positive previous family history,23 (76.66 %) had negative family history.

·      In the present study, minimumnumbers of patients were from Vata Pittaja Prakriti i.e., 6.66% patients were found, 36.66 % Pitta Kaphaja Prakriti & 56.66 % belongedto V**ata Kaphaja Prakriti.

·       In thepresent study 3.33% patients belong to Satvika Manasika Prakriti,whereas 96.66 % patients were of Rajasika Manasika Prakriti.

·       In thepresent study, 90% patients had MadhyamaSara, 3.33% were from Pravara Sara, and 6.66% were from Avara Sara.

·      In the present study, 83.33% patients were ofMadhyama Samhanana and 16.66% were from PravaraSamhanana.

·      In the present study, 93.33% patients were ofMadhyama Pramana and 6.66% were from Sama Pramana.

·       In thepresent study, maximum 73.33 % i.e., 11 patients showed Madhyama Satva, 20 % i.e., 3 patientshad Avara Satva while 6.66% were from Pravara Satva.

·      In the present study, maximum 96.66% i.e., 29 patients showed Madhyama Satmya, 3.33 % i.e., 1 patienthad Pravara Satmya.

·       In thepresent study, 6.66 % were having Pravara Abhyavaharana Shakti, 13.33 % had Avara, whereas80 % had Madhyama AbhyavaharanaShakti.

·       Inthe present study,maximum i.e., 24 (80%) patientsshowed Madhyam *Jarana Shakti,*4 (13.33 %) patients had Avara,whereas 1 patient i.e., (6.66 %) showed Prav**ara Jarana Shakti.

·      In the present study, maximum 20 patients(66.66 %) hadMadhyama *Vyayam Shakti ,*10 patients had (33.33 %) Avara Vyayama Shakti.

·      In the present study, maximum 21 patients(70 %) had Madhyama Koshtha, 1patient had (3.33 %) Mridu Koshtha while8 patients (26.66%) hadKrura Koshtha.

·      In the present study, maximum 18 patients(60 %) had Vishamagni, 06 patients(20 %) had Samagni, 04 (13.33 %)patients had Mandagni, while 2 (6.66%) patients had Tikshnagni out of 30 registered cases ofDyslipidemia*.*

·       Inthe present study, 24 (80 %) patients were taking vegetarian diet whereas 6 (20%) patients were taking mix diet among 30selected cases of Dyslipidemia.

·      In the present study, maximum i.e., 43.33% patients practiced Adhyashana, 30%patients practiced Vishamashana, 20 %patients showed habit of Samashana& 6.66 % patients practicedViruddhashan.

·       Inthe present study, 27 patients (90%) showed dominance of Madhur Rasa, 13(43.33%) patients showed Amla Rasa predominance, 20 patients showed Lavana Rasa predominance in (66.66 %),14 patients showed Katu Rasa predominance i.e., 46.66 %, no patient had TiktaandKashaya Rasa dominantin their diet.

·       Inthe present study, 23 patients (76.66 %) showed evidence of sound sleep, 08patients (26.66 %) showed evidence of excess sleeping habits, 1 patient (3.33%) showed habit of disturbed sleep.

·       Inthe present study, maximum 16 patients (53.33 %) had no habit of exercise and14 patients had habit of exercise (46.66 %).

·       Inthe present study, maximum 73.33 % patients had regular bowel habit and 26.66%patients had irregular/ constipated bowel habit.

·       Inthe present study, all the patients had Madhyama Mootra Pravriti.

·       Inthe present study,1 female patient had regular menstrual cycle (6.66%), 14female patients had menopause (93.33%).

·       Inthe present study, 18 patients had addiction of tea (60 %), 8 patients hadaddiction of coffee (26.66%), 2 patients had addiction of tobacco (6.66%).

·       Inthe present study, 36.66 % patient had SheetaGuna dominant, 93.33 % patients hadGuru Guna dominant, 90 % patients had Snigdha Guna dominant, 23.33 % had UshnaGuna dominant diet.

·       Inthe present study, maximum patients i.e., 29 (96.67 %) showed Godhuma Nidana Sevana, 28patients (93.34%) showed Dugdha Nidana Sevana, 27 (90 %)patients show Madhura and Guru Guna Nidana Sevana*.*

·      In the presentstudy, 25 (83.34 %) patients hadSukhashaiyasana**, 18 (60 %) patients had Diwaswapna, 16 (53.34%) patients had Avyayama*.*

·      In the presentstudy, 12 (50%) patients had Atichinta and15 *(*40%) patients had Harshanityatatva as Mansika Nidana.

·   In the presentstudy, 14 patients (46.67%) had height between 151-160 cms, 12 (40%) had height between161-170 cms, and 2 (6.67%) hadheight between 141-150 cms and 2 (6.67%) had height 171cms and above.

·      In the presentstudy, 17 patients (56.67%) had weight between 61-70 kgs, 9 (30%) had weightbetween 71-80kgs, 3 (10%) had weight between 51-60kgs and 1 (3.34%) had weightabove 90kgs

·In the presentstudy, 11patients (36.67 %) belonged to 25.0-27.0 kg/m2, 9 (30%) belonged to <25kg/m2, 7 (23.34%) belonged to 27.1-29.0 kg/m2, 2 (6.67%) belongedto 31.1-33.0 kg/m2   and 1 (3.34%) belonged to 29.1-31.0kg/m2 BMI.

·       In the present study, 40% of thepatients were having cholesterol <200mg/dl,followed by 33.34% having cholesterolbetween 200-239mg/dl & 26.67%of the patients were having cholesterol above 240mg/dl.

·       In the present study, 50% of thepatients were having serum triglyceride above 200mg/dl, followed by 33.33% having triglycerides levels below 150 mg/dl & 16.67% of the patients were having triglycerides in therange of 150-199mg/dl.

·      In the present study, 36.67% of the patients were having serum LDLless than 100mg/dl followed by 33.33%of the patients having serum LDL in the range of 100- 150mg/dl.26.67% of the patients having serum LDL in the range of 150- 190mg/dl & 3.34%patients were reported to have S.LDL more than 190mg/dl.

·      In the present study, 56.67% of the patients were having serum HDL inthe range of 40-60mg/dl followed by 36.67%of the patients were having S. HDL less than 40mg/dl and 6.67% of the patients were having the values above 60mg/dl.

·       In the present study, 40% of the patientswere having S. VLDL in the range of 20-40mg/dl followed by 23.33% of patients having S. VLDL less than 20 mg/dl. &20% of the patients having S. VLDL above 60mg/dl & 16.67% of the patients were having S. VLDL in therange of 40-60 mg/dl.

RESULTS

Resultsin Group A: - Triphaladi kwatha

In group A, highly significant resultswere observed in Alasya, Daurbalya, Atipipasa, Atinidra, Gatra Gaurav,Chala-Sphik-Udara-Stana, Atikshudha, Kshudra Shwas, Shithilangata weredecreased by 84.37%, 78.12%, 72.72%, 70.58%,70.58%, 50%, 60.71%,68.75%, 64.70% respectively. Significant results were observed in GatraDaurgandhya, Swedadhikya, Tandra, Angamarda and percentagewise decreased by50%, 58.82%,93.33%, 69.23% respectively.

In group A, highly significant resultswere observed in S. Total Cholesterol, S.Triglyceride, S.VLDL, S.HDL,WEIGHT, BMI and weredecreased by 10.25%, 20.89%, 14.94%, 14.42%, 4.54% and 4.53% respectively. Significantresults were observed in S. LDL and were decreased by 14.03%.

Resultsin Group B: - Mustadi kwatha

Inthe present study, in group B, highly significant results were observed in Chala-Sphik-Udara-Stana, Swedadhikya, Alasya, Daurbalya, Atinidra, Gatra Gaurav,Atikshudha, Tandra, Kshudra Shwasa, Angamarda, were decreased by 65.7%,64.70%, 85.71%, 86.11%, 66.66%, 80.55%, 62.5%, 62.96%, 88.88%, 73.33%respectively. Significant results were observed in Atipipasa, Gatra**Daurgandhya, Shithilangata were decreased by 71.42%, 57.142%,53.84% respectively.

In group B, highly significant resultswere observed in S. Total Cholesterol, S.Triglyceride, S.VLDL, S.HDL,WEIGHT, BMI and were decreased by 11.19%, 11.04 %, 16.88 %, 10.03 %, 3.84% and 3.87% respectively. Significant resultswere observed in S. LDL and were decreased by 14.03%.

OverallEffect of Therapies

•       In Group A: Mild Improvement was found in 13(86.66%), unchanged improvement was found in 2 (13.33%) patients.

•       In Group B: Moderate Improvement was found in 2(13.33%), Mild Improvement was found in 10 (66.66%), unchanged improvement wasfound in 3 (20%) of patients.

•       In Both Groups: Moderate Improvement was found in 2(6.66%), Mild Improvement was found in 23 (76.66%), unchanged improvement wasfound in 5 (16.66%) of

patients.

 DISCUSSION

The final section, titled discussion,includes brief description of the conceptual study, scientific interpretationof observations obtained, detailed description of the results and possible modeof action of treatment.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patient having abnormal one or more elevated lipid level in lipid profile investigation.

Exclusion Criteria

  • •Patient having very high level of cholesterol S. Total cholesterol.
  • •> 400 mg/dl S.Triglyceride.
  • •> 400 mg/dl S. LDL cholesterol.
  • •> 400 mg/dl S. HDL cholesterol.
  • •< 10 mg/dl S. VLDL cholesterol.
  • •> 200 mg/d 2)Known cases of Tuberculosis, Carcinoma, IDDM, CCF, HIV, Advanced stage of Diabetes Mellitus and HTN, Drug Induced Dyslipidemia, CNS disorders and any major liver and kidney disorder. 3)Patients having past history of MI and Unstable Angina. 4)Associated with any other serious systemic disease or complication, which leads to fatal conditions.

Outcomes

Primary Outcomes

Primary:-Results will be assesed on the basis of Lipid Profile Reports.

Time Frame: 8 weeks

Secondary Outcomes

  • Secondary- Results will be assessed on the basis of improvement in sign and symptoms of Medoroga and Ajirna(8 weeks)

Investigators

Sponsor
Government Akhandanand Ayurveda College And Hospital
Sponsor Class
Government medical college

Study Sites (1)

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