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CTRI Number  CTRI/2022/06/043410 [Registered on: 22/06/2022] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy Of Triphaladi Kwatha And Mustadi Kwatha In The Management Of Dyslipidemia 
Scientific Title of Study   Efficacy Of Triphaladi Kwatha And Mustadi Kwatha In The Management Of Dyslipidemia- An Open Labeled Randomized Clinico- Comparative Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khushali Bhatt 
Designation  Pg Scholar 
Affiliation  GOVERNMENT AKHANDANAND AYURVED COLLEGE AND HOSPITAL  
Address  Department Of Kayachikitsa OPD No. 4 Government Akhandanand Ayurveda College And Hospital Bhadra Ahmedabad

Ahmadabad
GUJARAT
380001
India 
Phone  9409527800  
Fax    
Email  khushalibhatt03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana Raval 
Designation  Assistant Professor 
Affiliation  GOVERNMENT AKHANDANAND AYURVED COLLEGE AND HOSPITAL  
Address  Department Of Kayachikitsa OPD No. 4 Government Akhandanand Ayurveda College And Hospital Bhadra Ahmedabad

Ahmadabad
GUJARAT
380001
India 
Phone  9824423090  
Fax    
Email  vandanaraval215@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vandana Raval 
Designation  Assistant Professor 
Affiliation  GOVERNMENT AKHANDANAND AYURVED COLLEGE AND HOSPITAL  
Address  Department Of Kayachikitsa OPD No. 4 Government Akhandanand Ayurveda College And Hospital Bhadra Ahmedabad

Ahmadabad
GUJARAT
380001
India 
Phone  9824423090  
Fax    
Email  vandanaraval215@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurveda College And Hospital Bhadra Ahmedabad  
 
Primary Sponsor  
Name  Government Akhandanand Ayurveda College And Hospital  
Address  Department Of Kayachikitsa OPD No. 4 Government Akhandanand Ayurveda College And Hospital Bhadra Ahmedabad 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Khushali Bhatt  Government Akhandanand Ayurveda College And Hospital   Department Of Kayachikitsa OPD No. 4 Government Akhandanand Ayurveda College And Hospital Bhadra Ahmedabad
Ahmadabad
GUJARAT 
9409527800

khushalibhatt03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, (2) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: STHOULYA, (3) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphaladi Kwatha, Reference: Charaka Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: Follow Up 4 weeks
2Intervention ArmDrugClassical(1) Medicine Name: Mustadi Kwatha, Reference: Charaka Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: Follow Up 4 weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patient having abnormal one or more elevated lipid level in lipid profile investigation. 
 
ExclusionCriteria 
Details  1)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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary:-Results will be assesed on the basis of Lipid Profile Reports.
 
8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary- Results will be assessed on the basis of improvement in sign and symptoms of Medoroga and Ajirna  8 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/06/2022 
Date of Study Completion (India) 31/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/08/2023 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

·       In this study, total 30 patients were registered and all patients had completed treatment along with follow- up.

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

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

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

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

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

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

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

·       In the present study 43.33 % patients were housewife, 43.33 % were doing service, 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 11 patients (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, minimum numbers of patients were from Vata Pittaja Prakriti i.e., 6.66% patients were found, 36.66 % Pitta Kaphaja Prakriti & 56.66 % belonged to Vata Kaphaja Prakriti.

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

·       In the present study, 90% patients had Madhyama Sara, 3.33% were from Pravara Sara, and 6.66% were from Avara Sara.

·       In the present study, 83.33% patients were of Madhyama Samhanana and 16.66% were from Pravara Samhanana.

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

·       In the present study, maximum 73.33 % i.e., 11 patients showed Madhyama Satva, 20 % i.e., 3 patients had 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 patient had Pravara Satmya.

·       In the present study, 6.66 % were having Pravara Abhyavaharana Shakti, 13.33 % had Avara, whereas 80 % had Madhyama Abhyavaharana Shakti.

·       In the present study, maximum i.e., 24 (80%) patients showed Madhyam Jarana Shakti, 4 (13.33 %) patients had Avara, whereas 1 patient i.e., (6.66 %) showed Pravara Jarana Shakti.

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

·       In the present study, maximum 21 patients (70 %) had Madhyama Koshtha, 1 patient had (3.33 %) Mridu Koshtha while 8 patients (26.66%) had Krura 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 of Dyslipidemia.

·       In the present study, 24 (80 %) patients were taking vegetarian diet whereas 6 (20 %) patients were taking mix diet among 30 selected 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 practiced Viruddhashan.

·       In the 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 Tikta and Kashaya Rasa dominant in their diet.

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

·       In the present study, maximum 16 patients (53.33 %) had no habit of exercise and 14 patients had habit of exercise (46.66 %).

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

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

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

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

·       In the present study, 36.66 % patient had Sheeta Guna dominant, 93.33 % patients had Guru Guna dominant, 90 % patients had Snigdha Guna dominant, 23.33 % had Ushna Guna dominant diet.

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

·       In the present study, 25 (83.34 %) patients had Sukhashaiyasana, 18 (60 %) patients had Diwaswapna, 16 (53.34%) patients had Avyayama.

·       In the present study, 12 (50%) patients had Atichinta and 15 (40%) patients had Harshanityatatva as Mansika Nidana.

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

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

·               In the present study, 11 patients (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%) belonged to 31.1-33.0 kg/m2   and 1 (3.34%) belonged to 29.1-31.0 kg/m2 BMI.

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

·       In the present study, 50% of the patients 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 the range of 150-199mg/dl.

·       In the present study, 36.67% of the patients were having serum LDL less 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 in the 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 patients were 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 the range of 40-60 mg/dl.

RESULTS

Results in Group A: - Triphaladi kwatha

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

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

 

Results in Group B: - Mustadi kwatha

            In the 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 results were 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 results were observed in S. LDL and were decreased by 14.03%.

Overall Effect 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 was found 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 was found in 5 (16.66%) of

patients.

 

DISCUSSION

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


 
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