| CTRI Number |
CTRI/2025/01/079380 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Impact of Saushthi Candy and Vati on Serum Calcium Levels of Postmenopausal Women |
|
Scientific Title of Study
|
A Comprehensive Study of Saushthi Candy and Vati on Postmenopausal Women |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF ANAND K CHAUDHARY |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF RASASHASTRA, FACULTY OF AYURVEDA,
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452074480 |
| Fax |
|
| Email |
anandayu@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF ANAND K CHAUDHARY |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF RASASHASTRA, FACULTY OF AYURVEDA,
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452074480 |
| Fax |
|
| Email |
anandayu@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR KANIKA NAINWAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF RASASHASTRA, FACULTY OF AYURVEDA,
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8755593313 |
| Fax |
|
| Email |
kanika.nainwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| BANARAS HINDU UNIVERSITY, VARANASI. 221005 |
|
|
Primary Sponsor
|
| Name |
BANARAS HINDU UNIVERSITY |
| Address |
FACULTY OF AYURVEDA, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, VARANASI. 221005 |
| 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 |
| KANIKA NAINWAL |
SIR SUNDERLAL HOSPITAL |
OPD NO. 11B (RASASHASTRA AND BHAISAJYA KALPANA), 21 AND 22 (KAYACHIKITSA), SIR SUNDERLAL HOSPITAL, BANARAS HINDU UNIVERSITY, VARANASI
Varanasi
UTTAR PRADESH |
8755593313
kanika.nainwal@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, VARANASI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E58||Dietary calcium deficiency. Ayurveda Condition: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Shelcal | Dose- 500mg, 1 Tablet OD with water | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Saushthi Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 800(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Saushthi Candy, Reference: NA, Route: Oral, Dosage Form: Gudpak, Dose: 4.5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Females of age 45-70 years who have attained menopause.
2. Patients having serum calcium level less than 8.9 mg/dl on examination.
|
|
| ExclusionCriteria |
| Details |
1. Patients with evidence of malignancy.
2. Patients with serum calcium level more than or equal to 8.9 mg/dl.
3. Patients suffering from any major diseases (eg. Diabetes Mellitus, Hypertension, Coronary Artery Disease, Stroke, Hypothyroidism or Hyperthyroidism, Hypoparathyroidism or Hyperparathyroidism, Renal or Hepatic Disease, or Malignant or Metabolic Bone Disease).
4. Patients receiving hormone, corticosteroid therapy and on long term
medication. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Objective Parameters such as
Serum Calcium, Serum Albumin, Serum Alkaline Phosphatase, Urine Calcium, Liver Function Test (LFT), Renal Function Test (RFT) will be assessed. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective parameters such as Paresthesia, Muscle Spasm, Cramp, Tetany, Circumoral Numbness, Seizures will be analysed over gradation scale. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The present study is entitled - A Comprehensive study of Saushthi Candy and Vati on Postmenopausal women. The study contains a literary review of the ingredients used in the preparation of products, analytical study of components, acute toxicity study and clinical study. After the study, the outcomes will be published in Indexed journals. Purpose of the trial - To evaluate the efficacy of Saushthi Candy and Vati in the management of Calcium deficiency/hypocalcaemia in postmenopausal women. This trial will develop clinical proof for Saushthi Candy and Vati as a herbo-mineral calcium supplement in postmenopausal women. |