FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/08/044626 [Registered on: 04/08/2022] Trial Registered Prospectively
Last Modified On: 29/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A Study to evaluate the response of Asthi Dhatu to Panchatikta Ghruta Guggulu based on Body constitution 
Scientific Title of Study   Evaluation of changes in the quality of Asthi Dhatu on administration of Panchatikta Ghruta Guggulu in middle aged osteoporotic individuals of different Deha Prakriti 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RESMI B G 
Designation  PhD scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  PhD Scholar Department of Kriya Sharir National Institute of Ayurveda Jaipur
Krishna ViLas, 56, New Aiswarya Nagar, Vadakkevila P O , Kollam Kerala 691010
Jaipur
RAJASTHAN
302002
India 
Phone  9895361423  
Fax    
Email  faribeker@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chhaju Ram Yadav 
Designation  Associate Professor & Head 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Kriya Sharir National Institute of Ayurveda Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9460866101  
Fax    
Email  dr.yadavcr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RESMI B G 
Designation  PhD scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  PhD Scholar Department of Kriya Sharir National Institute of Ayurveda Jaipur
PhD Scholar Department of Kriya Sharir National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9895361423  
Fax    
Email  faribeker@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda DU Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 
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 
RESMI B G  NIA Hospital Jaipur  Room no 3, Department of Kriya Sharir OPD National Institute of Ayurveda Hospital Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN 
9895361423

faribeker@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M169||Osteoarthritis of hip, unspecified. Ayurveda Condition: ASTHIKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Panchatikta Ghruta Guggulu, Reference: Bhaishajya Ratnavali 54/233-236, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: Group of VK/KV Prakriti individuals
2Comparator ArmDrugClassical(1) Medicine Name: Panchatikta Ghruta Guggulu, Reference: Bhaishajya Ratnavali 54/233-236, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: Group of VP/PV prakriti individuals
3Comparator ArmDrugClassical(1) Medicine Name: Panchatikta Ghruta Guggulu, Reference: Bhaishajya Ratnavali 54/233-236, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: Individuals of PK/KP Prakriti
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals who are identified as dwandwaja prakriti (not more than 10% difference between the predominant dosha and at least 10% difference with the least predominant dosha)
Individuals who are identified as having osteoporosis with respect to BMD T score (T score
< -2.5)
 
 
ExclusionCriteria 
Details  Individuals under any medication for systemic illnesses like morbid HTN, diabetes, Chronic respiratory illnesses etc.
Individuals who are under any hormone therapy/ steroids etc.
Individuals with any acute or chronic joint diseases like Gouty Arthritis, Rheumatoid arthritis etc.
Individuals with identified bone TB, bone tumor, osteomyelitis, osteomalacia, Paget’s disease etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in 3D DXA BMD
Serum Calcium
Vit D 
On day 1 and ON 46th day 
 
Secondary Outcome  
Outcome  TimePoints 
changes in the quality of Asthi Dhatu on administration of Panchatikta Ghruta Guggulu according to Dehaprakriti  Day 1 and on Day 46 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   02/09/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. But After completion of the study all the data obtained will be statistically analyzed and duly published in peer reviewed journal. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

INTRODUCTION:

As per Ayurveda, body is formed of Dosha, dhatu and mala. Among the seven dhatu, asthi dhatu is the fifth one which is having the function of giving support and stature to the body in normal condition. When the quantity or quality of asthi dhatu varies it reflects as various signs and symptoms in the body. The increase in asthi dhatu results in overgrowth of bones and teeth whereas the depletion in asthi dhatu causes falling of teeth, nails, body hairs and scalp hairs, dryness, roughness, looseness of joints, pricking pain in bones and desire for the meat attached to bones as food.Asthijanyavikara is recommended to be treated withtiktadravya and ksheeravastimade of tiktadravya.Now a day, the incidence of asthivikara is increasing enormously but usually in the initial stages it remains unnoticed.

Osteoporosis is a condition in which bones become weak and brittle. Normally, the body constantly absorbs and replaces bone tissue. With osteoporosis, new bone creation doesn’t keep up with old bone removal. The quality of bones changes where bone mineral density and bone mass decreases, eventually leading to bone fracture. But it is a silent disease that many people have no symptoms until they have a bone fracture. Osteoporosis can affect people of any age and ethnic group, but more prominent in old age and post-menopausal women. The most common test for measuring bone mineral density is dual-energy x-ray absorptiometry (DXA). It is a quick, painless, and non-invasive test. DXA uses low levels of x-rays as it passes a scanner over body of the subject lying in supine position on a cushioned table. The test measures the BMD of skeleton and at various sites that are prone to fracture, such as the hip and spine. Bone density measurement by DXA at the hip and spine is generally considered the most reliable way to diagnose osteoporosis and predict fracture risk. Treatment of osteoporosis includes medication, a healthy diet and weight-bearing exercise to help prevent bone loss or strengthen already weak bones. Dual Energy X-ray Absorptiometry is a widely accepted reference parameter to measure bone mineral density (BMD) at the spine and hip helping in diagnosing osteopenia, osteoporosis etc.

Prakriti is the unique concept of Ayurveda to assess the characteristic features of individuals based on their physical, psychological and physiological parameters. Simply prakriti can be said as the nature of an individual. It describes how a person is different from another individual. It is predetermined at the time of conception based on the predominance of doshas and remains unchanged throughout the life. It is the prime tool among dasavidhapareeksha for examining a patient. Considering the prakriti of an individual only, physician can arrive at a conclusion of choice of medicine, dosage, time and medium of administration. In short, we can say Prakriti is the Ayurvedic phenotyping method to categorize and identify people. Every person has his/her own unique constitution which determines the biological functions, response to environmental factors, drugs and also susceptibility to diseases making it one of the earliest known concepts of preventive and personalized medicine.

PREVALENCE: Worldwide, it is estimated that 1 in 3 women above the age of 50 will experience osteoporotic fractures, as well as 1 in 5 men. Studies indicate that osteoporosis and osteopenia or low bone mass may occur at a relatively younger age in Indian population. From India, reported prevalence of osteoporosis  from various studies among women is 8 to 62%. This shows wide variation in prevalence across India. Further, the risk of osteoporosis is higher in women than men and in elderly than young adults.  In line with this, recent study from North India reported higher osteoporosis prevalence in women (3 and 36.4% women aged 30 to 39 years and >70 years respectively) than men (0 and 5.6% for the two age groups respectively). A study in Delhi estimated the prevalence of osteoporosis as 24.6% in men and 42.5% in women above 50 years of age.

 NEED OF STUDY:

This alarming rise in bone disorder should be rightly addressed, otherwise the health of the future generation will be at stake succumbing to early osteoporosis and subsequent bone fractures. As per Ayurveda, many drugs and formulations have been mentioned for the management of asthijanyavikara. PanchatiktaGhrutaGuggulu is a proven formulation mentioned in BhaishajyaRatnavali. Dr. Ritesh et al has established the efficacy of Panchatikta Ghruta Guggulu in osteoporosis and its positive effect on asthimajjadhathu7. Though it has been proved that Panchatikta Ghruta Guggulu is having significant effect in improving the quality of asthi dhatu, it has not been proved that whether the effect of Panchatikta Ghruta Guggulu on the quality of asthi dhatu varies depending on prakriti of individual and if it varies, to what extent. The bioavailability of drugs, their metabolism and absorption rate etc may vary according to the prakriti of an individual. If some concluding findings can be made out on the effectiveness of this medicine based on prakriti of individual, it would help in the management of osteopenia, osteoporosis like asthikshayajanya vikara in a much focused and better modulated way. In this study individuals in the middle age group are the targets. As per Ayurveda classics, middle age is from 30 to 60 years. But the period of 30-40 years is of dhatusampoornata and after the age of 40 years only dhatukshaya occurs. So, here individuals of the age in the category 40-60 years are selected for the study8.

This study is an attempt to assess the influence of prakriti in the response of asthi dhatu to Panchatikta Ghruta Guggulu by administering Panchatikta Ghruta Guggulu in middle aged individuals of different dehaprakriti who are diagnosed as having osteoporosis.

 
Close