| CTRI Number |
CTRI/2024/08/072893 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of two medicine in osteopenia |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the effect of Trayodashanga Guggulu in the management of Osteopenia (Asthimajja kshaya) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Udit Saxena |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai. |
| Address |
Room no:17, Department of Kayachikitsa, Sri Jayendra Saraswathi collage and Hospital, Nazarathpet, Chennai.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8269191910 |
| Fax |
|
| Email |
robin.saxena5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvendu Rout |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi collage and Hospital, Nazarathpet, Chennai |
| Address |
Room no:17, Department of Kayachikitsa, Sri Jayendra Saraswathi collage and Hospital, Nazarathpet, Chennai.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444881980 |
| Fax |
|
| Email |
drsrout@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udit Saxena |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi collage and Hospital |
| Address |
Room no:17, Department of Kayachikitsa, Sri Jayendra Saraswathi collage and Hospital, Nazarathpet, Chennai.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8269191910 |
| Fax |
|
| Email |
robin.saxena5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital , Nazarathpet, Chennai, 600123, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Dr.Udit saxena |
| Address |
Sri Jayendra Saraswathi Ayurveda college and Hospital |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrUdit Saxena |
Sri Jayendra Saraswathi Ayurveda College and Hospital , Nazarathpet , Chennai |
Roon no.17 , Dept of Kayachikitsa,Sri Jayendra Saraswathi Ayurveda College and Hospital , Nazarathpet , Chennai
Thiruvallur
TAMIL NADU |
08269191910
robin.saxena5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital , Dept of Ayurveda of SCSVMV , Nazarathpet , Chennai 600123 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M859||Disorder of bone density and structure, unspecified. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trayodashyanga Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm Cow Milk), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: LAKSHA GUGGULU, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm Cow milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.T Score with -1 to -2.5
2. Clinical features of Osteopenia like Extreme fatigue, Body pain, Pain in back, vertebra , hip,distal forearm , tibia or any history of fracture or Minimal trauma |
|
| ExclusionCriteria |
| Details |
1. patients below the age 40 years and above 70 years, and pre diagnosed with Pathological osteopenia and Osteosarcoma , Hypercalcemia |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in T score and Reduction of signs and symptoms |
91th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
26/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteopenia is a clinical term used to describe a decrease in bone mineral density, yet not low enough to meet the diagnostic criteria to be considered Osteoporotic1. Osteopenia, as defined by the World Health Organization (WHO), is a t-score between -1 to -2.5, while values less than -2.5 are diagnostic for Osteopenia. Decreasing BMD values are reflective of an underlying disruption in the micro architecture of bone and Osteopenia, and Osteoporosis is considered quantitative, not qualitative, disorders of bone mineralization. The natural bone loss that occurs gradually during adulthood is considered to be the cause of primary form of Osteopenia and secondary form of Osteoporosis. Secondary causes serve to accelerate this process and include lifestyle factors such as alcohol use disorder, smoking, sedentary lifestyle, thin body habitus (BMI under 18.5 kg/m2) |