| CTRI Number |
CTRI/2024/06/068953 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of a traditionally found Indian delicacy (laddu) in curing calcium deficiency. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of a traditionally found calcium rich food supplement (laddu) in the management of asthi shosh (osteoporosis) caused due to calcium deficiency. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapnil Jaiswal |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda, Dr. Sarvepalli Radhakrishnan Ayurved University |
| Address |
Post Graduate Department of Swasthavritta and Yoga, Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Ayurved University, Karwad, Nagaur Road, Jodhpur, Rajasthan, India, 342037.
Jodhpur
RAJASTHAN
342037
India |
| Phone |
08209526615 |
| Fax |
|
| Email |
896swapnil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Agrawal |
| Designation |
Associate Professor, Department of Swasthavritta and Yoga. |
| Affiliation |
Post Graduate Institute of Ayurveda, Dr. Sarvepalli Radhakrishnan Ayurved University |
| Address |
Post Graduate Department of Swasthavritta and Yoga, Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Ayurved University, Karwad, Nagaur Road, Jodhpur, Rajasthan, India, 342037.
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9972143436 |
| Fax |
|
| Email |
drsaurabh101@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Agrawal |
| Designation |
Associate Professor, Department of Swasthavritta and Yoga |
| Affiliation |
Post Graduate Institute of Ayurveda, Dr. Sarvepalli Radhakrishnan Ayurved University. |
| Address |
Post Graduate Department of Swasthavritta and Yoga, Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Ayurved University, Karwad, Nagaur Road, Jodhpur, Rajasthan, India, 342037.
ROAD, JODHPUR RAJASTHAN, INDIA
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9972143436 |
| Fax |
|
| Email |
drsaurabh101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Ayurved University, Karwad, Nagaur Road, Jodhpur, Rajasthan, India. |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda |
| Address |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan, India, 342037. |
| 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 |
| Dr Swapnil Jaiswal |
Sanjeevani Hospital |
Room number 8, OPD Swasthavritta and Yoga, Sanjeevani Hospital, Post Graduate Institute of Ayurveda, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan, India.
Jodhpur
RAJASTHAN |
8209526615
896swapnil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M810||Age-related osteoporosis without current pathological fracture. Ayurveda Condition: ASTHISOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Nutracal, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Willingness and able to participate for 45 days.
Lactating mothers falling under the age group criteria.
T-score of BMD test -1 to -2.5 (osteopenia) and -2.5 and below (osteoporosis).
Classical symptoms of Asthi Sosha. |
|
| ExclusionCriteria |
| Details |
Patients below 40 years of age of both sexes.
T-score of BMD test –1 & above or –2.5 & below with bone fracture.
Juvenile Osteoporosis or Malabsorption syndrome.
Menopausal women with H.R.T.
Hypo or Hyperparathyroidism, Hypo or Hyperthyroidism.
Patient with history of fragility fracture and long bone fracture.
Patient under any drug which is known to affect bone metabolism. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in Bone mineral density |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decrease in Symptoms of Asthi shosh -
Asthi-Bheda Parva-Bheda Sandhi-Shool Santat-Ruka Mans-Kshaya Bala-Kshaya Aswapna
Pain Tenderness Swelling Stiffness Fatigue Restricted Movement Deformity |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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
|
An interventional study will be done on 50 patients with administration of a traditionally found calcium rich food supplement (laddu) for 45 days. The patients will be assessed on the basis of subjective and objective criteria for asthi shosh before and after trial. Follow up will done every 15th day. The data will be collected and analyzed statistically using appropriate tests. |