| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M169||Osteoarthritis of hip, unspecified. Ayurveda Condition: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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 | | 3 | Comparator Arm | Drug | Classical | | (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 |
|
|
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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. |