| CTRI Number |
CTRI/2019/06/019792 [Registered on: 20/06/2019] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical trial for safety and efficacy of grassroots leads in the management of Osteopenia / Osteoporosis among postmenopausal women. |
|
Scientific Title of Study
|
A randomized controlled, single blind clinical trial for safety and efficacy of grassroots leads in the management of Osteopenia / Osteoporosis among postmenopausal women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/ACA/2019/1-104 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Professor Sanjeev Sharma |
| Designation |
Director |
| Affiliation |
National institute of Ayurveda,Jaipur |
| Address |
Director office, National institute of Ayurveda, Jorawar Singh Gate, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8290996996 |
| Fax |
|
| Email |
profsanjeevhp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National institute of Ayurveda,Jaipur |
| Address |
Room no.2,Department of post graduate studies in Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur Rajasthan,India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National institute of Ayurveda,Jaipur |
| Address |
Room no.2,Department of post graduate studies in Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur Rajasthan,India
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| National innovation foundation, Grambharti,Amarapur,Gandhinagar, India |
|
|
Primary Sponsor
|
| Name |
National innovation foundation |
| Address |
National innovation foundation,Grambharti,Amrapur, Gandhinagar,Gujrat,India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Professor Sanjeev |
Madhav Vilas Hospital, National Institute of Ayurveda,Jaipur, |
Room no.2,Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,India
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
8290996996
profsanjeevhp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee National institute of Ayurveda Jaipur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1-Standard Ayurvedic drug |
Capsule containing Lakshadi Guggulu 330 mg and Praval pishti 85 mg in each capsule in a dose of 3 Capsule twitce a day,orally, after meal for one year
|
| Intervention |
Group 10 – NIF herbal grassroots lead 2 formulation 2 |
NIF herbal grassroots lead 2 formulation 2 in higher dosefor one year |
| Comparator Agent |
Group 2 – Standard Allopathic drug |
Tab. Shelcal (containing 1250 mg of Calcium carbonate
equivalent to 500 mg of elemental Calcium + Vitamin D3- 250
I.U.)
in a dose of 500 mg twice a day, orally,after meal for one year
|
| Intervention |
Group 3 - NIF herbal grassroots lead 1 formulation 1 |
NIF herbal grassroots lead 1 formulation 1 in lower dose for one year |
| Intervention |
Group 4 – NIF herbal grassroots lead 1 formulation 1 |
NIF herbal grassroots lead 1 formulation 1 in higher dose for one year |
| Intervention |
Group 5 – NIF herbal grassroots lead 1 formulation 2 |
NIF herbal grassroots lead 1 formulation 2 in lower dosefor one year |
| Intervention |
Group 6 – NIF herbal grassroots lead 1 formulation 2 |
NIF herbal grassroots lead 1 formulation 2 in higher dose for one year |
| Intervention |
Group 7 - NIF herbal grassroots lead 2 formulation 1 |
NIF herbal grassroots lead 2 formulation 1 in lower dose for one year |
| Intervention |
Group 8 – NIF herbal grassroots lead 2 formulation 1 |
NIF herbal grassroots lead 2 formulation 1 in higher dose for one year |
| Intervention |
Group 9 – NIF herbal grassroots lead 2 formulation 2 |
NIF herbal grassroots lead 2 formulation 2 in lower dose for one year |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Postmenopausal women, defined as no menstruation for the last 12 months.
2. B.M.D.T. Score -1 to -3.5 at hip, spine and forearm (worst score at any of
the three sites to be considered)
|
|
| ExclusionCriteria |
| Details |
1. B.M.D. T. score above -1 and less than -3.5
2. All women who are consuming any drug which is known to affect bone metabolism in doses for e.g. SERMs, bisphophonates, calcitonin, Vit. D more than 60,000 units and corticosteroids more than 5mg/day for more than 3 months, methotrexate, anticonvulsants and diuretics.
3. Patients suffering from congenital disorders (Dysosteogenesis and Marfan.s Syndrome)
4. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushing.s syndrome)
5. Patients with evidence of malignancy
6. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Epilepsy)
7. Patients suffering from chronic hepatic disorder, renal failure or cardiac dysfunction.
8. Patient suffering from uncontrolled DM-2 or uncontrolled hypertension.
8. Patients suffering from Osteomalacia.
9. Patients suffering from Malabsorption syndrome
10. Patients undergone Organ transplantation or on immunosuppressive therapy
11. Prolonged immobilization
12. Patients whose Serum Ca++ level < 2.2 or > 2.6 mmol/L (< 9 or >10.5 mg/dL)
13. History of renal stones
14. Long bone fracture in last 6 months.
15. Patient not ready to give an informed consent
16. Subjects who has participated in any other clinical study in last 30 days.
17. Patients with clinical evidence of active and chronic illness as rheumatoid arthritis, gout,SLE, Psoriatic arthritis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the safety and efficacy of Grassroots leads with Ayurvedic drug (Lakshadi Guggulu and Praval Pishti) and Allopathic drug(Shalcal) in subject with postmenopausal osteoporosis. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the biomarker response for bone formation of study drugs in postmenopausal osteoporosis
|
1 year |
| Mean changes in quality of life among women suffering from postmenopausal osteoporosis |
1 year |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="360" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
03/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This randomized multi arm controlled, single blind clinical trial was done for safety and efficacy of two grassroots leads in the management of osteopenia/ osteoporosis among postmenopausal women. Two grassroots leads in two different formulation and in two different doses were compared against standard Ayurvedic drug and standard allopathic drug.Each group was given one year of medication. |