FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092421 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to assess the effect of Kala basti krama with Rasnadi Niruha and Anuvasana(medicated enema treatment with alternate decoction and oil for 15 days period) in treatment of Prameha poorvaroopavastha(Prediabetic patients)  
Scientific Title of Study   An open randomized clinical control study to assess the effect of Kala basti krama with Rasnadi Niruha and Anuvasana in Prameha poorvaroopavastha wsr to prediabetic condition 
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 Neeraja Suresh Iyer 
Designation  PG Student 
Affiliation  R.A Podar Ayurvedic Medical College 
Address  OPD 7, Panchakarma OPD, Department of Panchakarma, R.A Podar Ayurvedic Medical College Dr Annie Besant road, Worli Mumbai, 400018

Mumbai
MAHARASHTRA
400018
India 
Phone  9850962367  
Fax    
Email  mimo1799@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Seema Bahatkar 
Designation  MD and Phd Panchakarma, HOD and Professor Panchakarma Department 
Affiliation  M.A Podar Ayurvedic Hospital Worli Mumbai 
Address  OPD 7,Panchakarma OPD, Department of Panchakarma, M.A Podar Ayurvedic Hospital Dr Annie Besant road, Worli Mumbai, 400018

Mumbai
MAHARASHTRA
400018
India 
Phone  9881900560  
Fax    
Email  seemabahatkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neeraja Suresh Iyer 
Designation  PG Student 
Affiliation  R.A Podar Ayurvedic Medical College 
Address  OPD 7, Panchakarma OPD, Department of Panchakarma, R.A Podar Ayurvedic Medical College,Dr Annie Besant road, Worli Mumbai, 400018

Mumbai
MAHARASHTRA
400018
India 
Phone  9850962367  
Fax    
Email  mimo1799@gmail.com  
 
Source of Monetary or Material Support  
M.A Podar Ayurvedic Medical Hospital ,Dr Annie Besant Road Worli , Mumbai 
 
Primary Sponsor  
Name  R.A Podar Ayurvedic Medical College Worli Mumbai 
Address  Department of Panchakarma, R.A Podar Ayurvedic Medical College , Dr Annie Besant Road, Worli ,Mumbai 400018 
Type of Sponsor  Government medical college 
 
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 Neeraja Suresh Iyer   M.A Podar Ayurvedic Hospital, Worli ,Mumbai  Department of Panchakarma, M.A Podar Ayurvedic Hospital,Worli , Mumbai,400018
Mumbai
MAHARASHTRA 		 9850962367

mimo1799@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee R.A Podar Ayurvedic Medical College and M.A Podar Ayurvedic Hospital Worli Mumbai  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: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म Pradhan Karma(Procedure Reference: Ch.Si.3/19, Procedure details: Patient is made to lie in left lateral position with right leg bent at knee. Lubricate the tip of catheter with oil. Apply oil on the anal orifice. Slowly insert the catheter into the anus ,slowly release the clip and allow the Basti medicine to flow into the rectum. Carefully remove the catheter.)
(1) Medicine Name: Rasnadi Niruha Basti, Reference: Ch.Si.3/61-64, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 765(ml), Frequency: od, Duration: 6 Days
(2) Medicine Name: Rasnadi Anuvasana, Reference: Ch.Si.3/61-64 and Sharangdhar Samhita Madhyam Khanda, Adhyay 9 Shloka 1, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 120(ml), Frequency: od, Duration: 9 Days
2Comparator ArmProcedure-saravA~gga, सर्वांग  (Procedure Reference: Ch.Su.5/86, Procedure details: Patient is made to lie in supine position. Lukewarm Til Tail is gently applied to body parts of patient.)
(1) Medicine Name: Til Tail, Reference: Ch.Su.13/12, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 15 Days
3Comparator ArmProcedure-sa~gkarasvedaH, संकरस्वेदः (Procedure Reference: Ch.Su.14/43, Procedure details: Steam is made by boiling Dashamool Kwath and passed over body parts of patient.)
(1) Medicine Name: Dashamool Kwath, Reference: Ch.Su.14/43, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 15 Days
4Intervention ArmProcedure-saravA~gga, सर्वांग  (Procedure Reference: Ch.Su.5/86, Procedure details: Patient is made to lie in supine position. Lukewarm Til Tail is gently applied to body parts of patient.)
(1) Medicine Name: Til Tail, Reference: Ch.Su.13/12, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 15 Days
5Intervention ArmProcedure-sa~gkarasvedaH, संकरस्वेदः (Procedure Reference: Ch.Su.14/43, Procedure details: Steam is made by boiling Dashamool Kwath and passed over body parts of patient.)
(1) Medicine Name: Dashamool Kwath, Reference: Ch.Su.14/43, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 15 Days
6Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म Pradhan Karma(Procedure Reference: Ch.Si.3/19, Procedure details: Patient is made to lie in left lateral position with right leg bent at knee. Lubricate the tip of catheter with oil. Apply oil on the anal orifice. Slowly insert the catheter into the anus ,slowly release the clip and allow the Basti medicine to flow into the rectum. Carefully remove the catheter.)
(1) Medicine Name: Panchatikta Panchaprasrutiki Basti, Reference: Vangasen Basti Adhyay ,61, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 675(ml), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients with fasting blood glucose levels between 110-125mg/dl
2)Patients with post prandial blood glucose levels between 140-200 mg/dl
3)Patients with grade 0-2 of any 3 of the following signs and symptoms of poorvaroopavastha of prameha
a)Swedadhikya
b)Shayyasana swapnasukham
c)Karapadadaha or Karapadasuptata
d)Atitrushna
e)Angagauravta
 
 
ExclusionCriteria 
Details  1)Patients with presenting complications of diabetes like diabetic nephropathy, retinopathy.
2)Patients with anorectal disorders like piles, fissure, fistula.
3)Patients with renal disease.
4)Patients with hyperuricemia
5)Patients with any form of malignancy.
6)Pregnant and lactating mothers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective and objective criteria of poorvaroopavastha of Prameha  Day 45.
Follow up on Day 1 . Day 15 and Day 45 
 
Secondary Outcome  
Outcome  TimePoints 
Imporovement in fasting blood glucose levels.  Day 45 
Improvement in post prandial blood glucose levels.  Day 45 
Improvement in grades of signs and symptoms of poorvaroopavastha of prameha-
Swedadhikya, Shayyasana swapnasukha, Karapada daha or suptata, Atitrushna and Angagauravta 		 Day 45 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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/ Phase 3 
Date of First Enrollment (India)   16/08/2025 
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="1"
Months="4"
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   Prediabetes is a condition in which blood sugar levels are higher than normal but not high enough to be caused diabetes.
It is one of the lifestyle disorders which is caused due to improper food , lifestyle and stress.

If patient is not treated at prediabetes stage, it may cause diabetes mellitus in future. Diabetes mellitus affects all systems of the body and can cause further complications.

So it is very important that patient should be assessed and treated in Prediabetes stage.
Ayurveda also believed that any disease should be treated in poorvaroopavastha.
So I have selected this disease.

Kala Basti krama with Rasnadi Niruha and Anuvasana have been selected because it has all tikta, katu rasatmak , rooksha drugs which will act on kapha dosha  and prameha vyadhi.

The study is divided into 2 arms with 32 participants each.
Intervention arm - Kala  Basti  krama  with Rasnadi Niruha and Anuvasana will be given for a period of 15 days.
Control arm  - Panchatikta Panchaprasrutiki Basti will be given for a period of 15 days.

Participants will be selected as per inclusion criteria.

Computer based Randomization process will be used.

Patients will be assessed on Day 1, Day 15 and Day 45 of study.

Patients will be assessed as per subjective and objective criteria.
Objective criteria-  Fasting blood sugar levels, Post Prandial  Blood Glucose levels.
Subjective criteria - Signs and Symptoms of poorvarropavastha of prameha 

 
Close