| CTRI Number |
CTRI/2025/05/087273 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Haldi and Amalaki in Diabetes melitus type 2 |
|
Scientific Title of Study
|
Comparative study of Nisha Swaras bhavit Amalaki churna
and Nishamalaki churna in Prameha w.s.r. to Diabetes
Mellitus Type-2 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Chandresh Nakum |
| Designation |
PG Scholar |
| Affiliation |
Govt. Ayurvedic College & Hospital ,near budhdhmurti,Kadamkuan,Patna, Bihar 800003 |
| Address |
Department of Dravyaguna, Government Ayurvedic
college & Hospital,near budhmurti,Kadamkuan,patna.
Patna
BIHAR
800003
India
Patna
BIHAR
800003
India |
| Phone |
7990012985 |
| Fax |
|
| Email |
nakumchandresh11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Mahendraprasad Singh |
| Designation |
Associate Professor Department of Dravyaguna |
| Affiliation |
Govt. Ayurvedic College and Hospital, Near Budhdhamurti, kadamkuan, Patna,Bihar 800003 |
| Address |
Department of Dravyaguna, Government Ayurvedic
college & Hospital,near budhmurti,Kadamkuan,patna.
Patna
BIHAR
800003
India
Patna
BIHAR
800003
India |
| Phone |
9431040125 |
| Fax |
|
| Email |
mahendrakiran1959@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof Mahendraprasad Singh |
| Designation |
Associate Professor Department of Dravyaguna |
| Affiliation |
Govt. Ayurvedic College and Hospital, near budhdhmurti, kadamkuan, Patna, Bihar 800003 |
| Address |
Department of Dravyaguna, Government Ayurvedic
college & Hospital,near budhmurti,Kadamkuan,patna.
Patna
BIHAR
800003
India
Patna
BIHAR
800003
India |
| Phone |
9431040125 |
| Fax |
|
| Email |
mahendrakiran1959@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic College & Hospital Near Buddhamurti Kadamkuan Patna 800003 |
|
|
Primary Sponsor
|
| Name |
Vd Chandresh Nakum |
| Address |
Govt Ayurvedic College & Hospital Near Buddhamurti Kadamkuan Patna Bihar 800003 |
| 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 Chandresh Nakum |
Govt Ayurvedic College & Hospital |
OPD NO.10, Govt Ayurvedic College & Hospital Near Buddhamurti Kadamkuan Patna Bihar 800003
Patna
BIHAR |
7990012985
nakumchandresh11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nishamalaki Churna, Reference: Ashtanga Hridaya Uttar tantra 40/48, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NISHA SWARAS BHAVIT AMALAKI CHURNA, Reference: Ashtanga Hridaya Uttar tantra 40/48, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Age group between 20-60 years.
b) Selected sign and symptoms based on both ayurvedic and modern
context
c) Impaired fasting glucose (Exceed normal fasting level)
d) Impaired PPBS 2 hours (Exceed the normal level)
e) Patients willing to give their consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
a) Age group below 20 and above 60 years.
b) They having advanced renal or liver disease etc.
c) Patients having any other systemic illness like active
tuberculosis, carcinoma or endocrine disorders like cushing
syndrome, hypothyroidism etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in sign and symptoms of Prameha i.e.
PRABHUTA MUTRATA
AVIL MUTRATA
KAR - PADA DAHA
KAR-PADA SUPTATA
DAURBALYA
PIPASA ADHIKYA
KSHUDHA ADHIKYA
GALA-TALU SHOSHA |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Changes in Biochemical investigation FBS & PP2BS |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
04/06/2025 |
| 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="0"
Months="6"
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
|
This study is a randomized, participant blinded, parallel group, interventional prospective trial Comparative study of Nisha Swaras bhavit Amalaki churna and Nishamalaki churna in Prameha w.s.r. to Diabetes Mellitus Type-2, that will be conducted in Government Ayurvedic Medical College and Hospital at Patna, Bihar in OPD No.10. In each group of 30 patients, Nisha Swaras bhavit Amalaki churna will be given in dose of 3 gm twise a day half an hour before having a meal and total 4 follow up will be done and and in the another group Nishamalaki churna will be given in dose of 3 gm twise a day half an hour before having a meal and total 4 follow up will be done. Post intervention follow-up will be done every 15 days for total duration of study i.e. of 60 days |