| CTRI Number |
CTRI/2026/04/107485 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Effect of Kala basti krama of Deepana Basti & Kala basti krama Panchtikta Panchprasutik Basti in Prediabetic Individuals on Blood sugar level & Metabolic Parameters . |
|
Scientific Title of Study
|
A comparative clinical trial to study the effect of Kala basti krama of Deepan basti and Kala basti krama of Panchtikta panchprasrutik basti in the management of Prameha purvaroopa avastha w.s.r. to prediabetes |
| 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 Revati Vinod Shinde |
| Designation |
PG Student |
| Affiliation |
R. A. Podar Aurvedic Medical College |
| Address |
OPD 7,Panchakarma OPD, Department of Panchkarma , R.A.Podar Medical College, Dr Annie Besant Road, Worli, Mumbai, 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8828055247 |
| Fax |
|
| Email |
revativshinde95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Bahatkar |
| Designation |
MD , PhD , HOD of Department of Panchakarma |
| Affiliation |
R. A. Podar Aurvedic Medical College |
| Address |
OPD 7,Panchakarma OPD, Department of Panchkarma , R.A.Podar Medical College, 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 Revati Vinod Shinde |
| Designation |
PG Student |
| Affiliation |
R. A. Podar Aurvedic Medical College |
| Address |
OPD 7,Panchakarma OPD, Department of Panchkarma , R.A.Podar Medical College, Dr Annie Besant Road, Worli, Mumbai, 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8828055247 |
| Fax |
|
| Email |
revativshinde95@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.A.Podar Ayurvedic Medical Hospital,Dr Annie Besant Road, Worli,India,Maharashtra, Mumbai-400018 |
|
|
Primary Sponsor
|
| Name |
R.A.Podar Ayurvedic Medical College, Worli, Mumbai |
| Address |
Department of Panchkarma , R.A.Podar Medical College, Dr Annie Besant Road, Worli, Mumbai, 400018 |
| 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 Revati Vinod Shinde |
M. A. Podar Aurvedic Hospital, Worli, Mumbai |
Department of Panchkarma , R.A.Podar Medical College, Dr Annie Besant Road, Worli, Mumbai, 400018
Mumbai
MAHARASHTRA |
08828055247
revativshinde95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee R.A.Podar ayurved medical college worli mumbai |
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: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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: Tila Taila, Reference: Ch.Su.13/12, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Ch.Su.14/43, Procedure details: Steam is made by boiling Dashamool Kwath & passed over body parts of patient.)
(1) Medicine Name: Dashmool Kwatha, Reference: Ch.Su.14/43, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 16 Days | | 3 | Comparator Arm | Procedure | - | 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: Tila Taila , Reference: Ch.Su.13/12, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 16 Days | | 4 | Comparator Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Ch.Su.14/43, Procedure details: Steam is made by boiling Dashamool Kwath & passed over body parts of patient.)
(1) Medicine Name: Dashmool Kwatha , Reference: Ch.Su.14/43, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 16 Days | | 5 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (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 & allow the Basti medicine to flow into the rectum. Carefully remove the catheter.)
(1) Medicine Name: Deepana Niruha Basti, Reference: Ch.Si 12/17, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 450(ml), Frequency: od, Duration: 6 Days(2) Medicine Name: Tila taila, Reference: Ch.Vi.8/150 ch.su 13/12, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 10 Days | | 6 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (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 & allow the Basti medicine to flow into the rectum. Carefully remove the catheter.)
(1) Medicine Name: Panchtikta Panchprasutik, Reference: Vangsen Basti Adhyay 61, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 450(ml), Frequency: od, Duration: 6 Days(2) Medicine Name: Tila Taila, Reference: Ch.Vi 8/130, Ch.Su 13/12, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient fit for basti.
2. Patients with prediabetic condition in type 2 diabetes mellitus.
3. Patients of any Gender between 18-60 years Age
4. Patients with fasting blood glucose levels between 100-125 mg/dl(3)
5. Patients with post prandial blood sugar levels between 140-200 mg/dl (3)
6. Patients with HbA1c levels between 5.7-6.4%(3)
7. Patients with signs and Symptoms of purvaroopavastha of prameha like karapadatala dah,
nidradhikya, swedadhikya etc |
|
| ExclusionCriteria |
| Details |
1. Patients not fit for basti (eg.anorectal disorders like piles, fissure, fistula etc.)
2. Patients with type 1 diabetes mellitus or insulin dependent diabetes mellitus.
3. Patients who taking Anti-diabetic medicine.
4. Patients with presenting complications of diabetes like diabetic nephropathy, diabetic
retinopathy.
5. Patients with immunocompromised diseases.
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 & objective criteria of purvaroopavastha of prameha |
4 weeks
Follow up on 2nd week and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in fasting blood glucose level
|
4 weeks |
| Improvment in Post prandial blood glucose level |
4 weeks |
| Improvment in grades of signs & symptoms of Purvaroopavastha of prameha- swedadhikya, nidradhikya, hasta-pada-tala daha,pipasadhikya |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/04/2026 |
| 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 purvaroopavastha. So I have selected this disease.
Comparative study of Kala Basti krama with deepana basti kala basti krama with Panchtikta panchprasutiki basti have been selected because they 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 deepana Niruha and Anuvasana with tila taila will be given for a period of 16 days. Comparator arm -Kala Basti krama with Panchatikta Panchaprasrutiki niruha Basti and Anuvasana with tila taila for period of 16 days
Participants will be selected as per inclusion criteria.
Computer based Randomization process will be used.
Patients will be assessed on Day 1, Day 16 and Day 24 & Day 32 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 purvarropavastha of prameha |