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CTRI Number  CTRI/2025/05/086548 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 26/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   To study the role of ayurvedic treatment (Panchatikta panchprasritika basti and nishakatakadi yoga) in diabetes. 
Scientific Title of Study   A comparative clinical study to evaluate the effect of Panchatikta Panchprasritika Basti and Nishakatakadi Yoga in management of Madhumeha with special reference to diabetes mellitus type 2 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Namita 
Designation  PG Scholar 
Affiliation  Government Ayurvedic College, Patna 
Address  Department of Panchakarma, Government Ayurvedic College, near Budhmurti, Kadamkuan, Patna, Bihar

Patna
BIHAR
800003
India 
Phone  09568928848  
Fax  -  
Email  namitakamat63@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhilesh Prasad Singh 
Designation  HOD, Associate Professor , Department of Panchakarma 
Affiliation  Government Ayurvedic College, Patna 
Address  Department of Panchakarma, Government Ayurvedic College, near Budhmurti, Kadamkuan, Patna, Bihar

Patna
BIHAR
800003
India 
Phone  8002680973  
Fax  -  
Email  drapsinghpatna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh Prasad Singh 
Designation  HOD, Associate Professor , Department of Panchakarma 
Affiliation  Government Ayurvedic College, Patna 
Address  Department of Panchakarma, Government Ayurvedic College, near Budhmurti, Kadamkuan, Patna, Bihar

Patna
BIHAR
800003
India 
Phone  8002680973  
Fax  -  
Email  drapsinghpatna@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College,near Buddha murti, Kadamkuan, Patna- 800003,Bihar India 
 
Primary Sponsor  
Name  Dr Namita 
Address  Department of Panchakarma, Government Ayurvedic College, near Buddhamurti, Kadamkuan- 800003, Patna, Bihar, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namita  Government Ayurvedic College, Kadamkuan 800003, Patna, India  OPD -11, Department of Panchakarama, Government Ayurvedic College, near Buddhamurti, Kadamkuan, Patna, Bihar
Patna
BIHAR 		 9568928848
-
namitakamat63@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charak siddhi sthan 8/8, Procedure details: The basti will be administered via rectal route once daily in morning before meal for 15 days )
(1) Medicine Name: Panchatikta Panchprasritika basti, Reference: Charak samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 15 Days
2Comparator ArmDrugClassical(1) Medicine Name: Nishakatakadi yoga, Reference: Sahastra yoga (10/55), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient willing to sign consent form for the
clinical trial.
2. Patient with FBS in range of 126 to 200 mg per
dl
PPBS in range of 200 to 300 mg per dl.
3. Patient between age group of 18 to 60
irrespective of their gender or socio economic
status.
4. Patients having no known complication of
disease.
 
 
ExclusionCriteria 
Details  1. Patient not giving the consent .
2. Patients having Type 1 Diabetes Mellitus.
3. FBS greater than 200 mg per dl and PPBS greater
than 300 mg per dl.
4. Patients of Type 2 diabetes mellitus who are on
insulin therapy.
5. Type-2 diabetes mellitus with complications and
Madhumeha with Ashadhya upadrava.
6. Patients having any serious illness like
cardiovascular diseases, renal disease, hepatic
disease, malignancy, any other endocrinopathies
etc.
7. Pregnant and lactating mother.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in the objective parameters- F.B.S., P.P.B.S. from baseline values.  62 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the clinical symptoms of Mahdumeha (Type 2 diabetes mellitus)
 		 Time frame baseline to end of 62nd day 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   07/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/05/2025 
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 randomized, open, interventional prospective trial comparing the effect of Panchatikta Panchprasritika Basti and Nishakatakadi yoga in management of madhumeha with special reference to diabetes mellitus type 2, that will be conducted in Government Ayurvedic College and Hospital , Patna, Bihar in the department of Panchakarma. The study will be conducted in Government Ayurvedic College and Hospital, Patna, Bihar in department of Panchakarma. After intervention follow up will be done every 8 th day for total duration of study i.e. 62 days.  
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