| CTRI Number |
CTRI/2021/01/030660 [Registered on: 21/01/2021] Trial Registered Prospectively |
| Last Modified On: |
20/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Other (Specify) [Vati] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Nisha-Amalaki Churna and Shilajeet Vati in Prameha (Pre-Diabetic) |
|
Scientific Title of Study
|
A clinicopathological study on Prameha Purvarupa (Pre-Diabetic Condition) and its management with Nisha-Amalaki Churna and Shilajeet Vati |
| Trial Acronym |
NACSV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Esha Dhiman |
| Designation |
P G Scholar |
| Affiliation |
Govt Ayurvedic College and Hospital Balangir |
| Address |
Department of Roga Nidana Evam Vikriti Vigyana Govt Ayurvedic College and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
8219083340 |
| Fax |
|
| Email |
dr.eshatomar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Pradip Kumar Panda |
| Designation |
Professor and HOD |
| Affiliation |
Govt Ayurvedic College and Hospital Balangir |
| Address |
Department of Roga Nidana Evam Vikriti Vigyana Govt Ayurvedic College and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
9437150643 |
| Fax |
|
| Email |
drpkpandanidan@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Pradip Kumar Panda |
| Designation |
Professor and HOD |
| Affiliation |
Govt Ayurvedic College and Hospital Balangir |
| Address |
Department of Roga Nidana Evam Vikriti Vigyana Govt Ayurvedic College and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
9437150643 |
| Fax |
|
| Email |
drpkpandanidan@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Esha Dhiman, Department of Roga Nidana Evam and Vikriti Vigyana Govt Ayurvedic College and Hospital Balangir |
|
|
Primary Sponsor
|
| Name |
Esha Dhiman |
| Address |
Department of Roga Nidana Evam and Vikriti Vigyana Govt Ayurvedic College and Hospital Balangir |
| Type of Sponsor |
Other [Government Ayurvedic College & Hospital] |
|
|
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 |
| Prof Dr Pradip Kumar Panda |
Govt Ayurvedic College & Hospital Balangir |
OPD & IPD of Govt Ayurvedic College & Hospital Balangir
Balangir
ORISSA |
9437150643
drpkpandanidan@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt Ayurvedic College & Hospital Balangir, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nisha-Amalaki Churna |
Nisha-amalaki churna 3 gm twice daily, empty stomach for 30 days. |
| Comparator Agent |
Shilajeet Vati |
Shilajeet Vati having (500mg) 1 vati Twice daily, empty stomach for 30 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Both new and treated cases will be included.
2. Patients who fulfill the diagnostic criteria.
3. Patients age between 30-65 years.
4. Patients having fasting plasma glucose 100-
125 mg%
5. Patients having oral glucose tolerance 140-
200 mg%
6. Patients with HbA1c 5.7%-6.4%
7. Patients having symptoms of Prabhuta mutrata
(frequency of micturition), pipasa (increased
thirst), kshudha (excessive appetite), kara-
pada daha (burning sensation in hand and
feet), kara-pada suptata (numbness of hand
and feet), sweda pravritti (excessive
sweating), mukha shosha (dry mouth), mukha
madhurya (sweetness in mouth), sheeta priyata
(liking for cold things) madhura shukla
mutrata (sweetness in urine).
8. Subject willing to follow the procedures as
per the study protocol and voluntarily
signing informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients age <30 years and >65 years .
2. Patients having fasting plasma glucose >
125mg%
3. Patients having oral glucose tolerance >
200mg%
4. Patients with HbA1c 6.5% or more.
5. Patients having complications of diabetes
like ketoacidosis, nephropathy, neuropathy,
retinopathy, and diabetic wounds.
6. Patients having chronic, contagious infection
disease such as active tuberculosis, hepatits
B or C, or HIV
7. Pregnant and lactating females.
8. Patients having active metabolic or
gastrointestinal disease that may interfere
with nutrient absorption, metabolism,
excretion, excluding diabetes.
9. Type-1 diabetes mellitus and Type-2 diabetes
mellitus.
10. Any other patient considered not fit for
trial.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To control the symptoms of Prameha Purvarupa |
To control the symptoms of Prameha Purvarupa |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nisha-amalaki churna is more effective than Shilajeet vati individually. |
31 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="15"
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 1 |
|
Date of First Enrollment (India)
|
25/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/01/2021 |
| 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
|
The study will be submitted in the form of Dissertation to Sambalpur University as a part of Post Graduate Course |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Clinico- Pathological Study on Prameha Purvarupa i.e Pre- Diabetic condition and its management with Nisha-Amalaki Churna and Shilajeet Vati. This is done compulsory part of Post Graduate Course. Total No. of Patients to be studied is 30 with duration of 30 days. |