| CTRI Number |
CTRI/2025/03/082911 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative clinical trial to study the effects of modified mustadi yapana basti and bhadranimbadi asthapana basti in patients with prameha poorvarupa w.r.s pre-diabetes |
|
Scientific Title of Study
|
A randomized comparative clinical trial study to evaluate the efficacy of modified Mustadi Yapana basti and Bhadranimbadi Asthapana basti in the management of Prameha Poorvarupa 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 Krupa Parmar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Department of Panchkarma, second floor room number 303 Parul Institute of Ayurveda, Parul University, PO Limda, Ta Waghodia, 391760, Vadodara, Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
9265446493 |
| Fax |
|
| Email |
parmarkrupa41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta H Toshikhane |
| Designation |
Professor, Department of Panchakarma, Parul Institute of Ayurved, Parul University |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room no. 303, Department of Panchakarma, Parul Institute of Ayurveda, Parul University, Limda, Vadodara, Gujarat, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9964596479 |
| Fax |
|
| Email |
sangeeta.toshikhane26791@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta H Toshikhane |
| Designation |
Professor, Department of Panchakarma, Parul Institute of Ayurved, Parul University |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room no. 303, Department of Panchakarma, Parul Institute of Ayurveda, Parul University, Limda, Vadodara, Gujarat, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9964596479 |
| Fax |
|
| Email |
sangeeta.toshikhane26791@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Panchkarma-OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat, India, Pin no-391760 |
|
|
Primary Sponsor
|
| Name |
Parul Ayurved Hospital |
| Address |
Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul university, limda, vadodara, gujarat, India pin no-391760 |
| Type of Sponsor |
Research institution and 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 |
| Dr Krupa Parmar |
Parul Institute of Ayurved |
Panchakarma- OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat.
Vadodara
GUJARAT |
9265446493
parmarkrupa41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE for human research Parul Institute of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Mustadi Yapana basti : Charaka samhita siddhisthan chapter 12, shloka 15, Procedure details: POORVAKARMA:
Selection of the patient, counselling of patient, basti preparation.
Deepana-pachana with chitrakadi vati 2 TID after food ( for first two days)
sadhyo virechana with eranda taila 10 ml at night after food (on 2nd day of intervention)
PRADHANAKARMA:
Modified mustadi yapana basti administration in the early morning, empty stomach between 8 to 9 am for 8 days.
PASCHATKARMA:
Rest, snana, light food advised.)
(1) Medicine Name: Chitrakadi vati , Reference: charaka samhita chikitsasthan 15/96-97, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 2 Days(2) Medicine Name: Eranda taila , Reference: charaka samhita chikitsasthana 26/27-31, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Duration: 1 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Bhadranimbadi Asthapana basti : Sushruta samhita chikitsasthana chapter 38, shloka 60-62, Procedure details: POORVAKARMA:
Selection of the patient, counselling of patient, basti preparation.
Deepana- pachana with chitrakadi vati 2 TID after food for first two days
Sadhyo virechana with eranda taila 10 ml at night after food (on 2nd day of intervention)
PRADHANAKARMA:
Administration of modified bhadranimbadi asthapana basti in the early morning, empty stomach between 8 to 9 am for 8 days.
PASCHATKARMA:
Rest, snana, light food advised.)
(1) Medicine Name: Chitrakadi vati, Reference: Charaka samhita chikitsa sthana 15/96/97, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 2 Days(2) Medicine Name: Eranda taila, Reference: Charaka samhita chikitsa sthana 26/27-31, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender between age group of 18 to 60.
2. Patients fulfilling the criteria of diagnosis according to american diabetes association (hbA1C - 5.7% - 6.4%)
3. Patients suitable for basti karma
4. Patients having BMI 22.2 kg/m2 - 29.9 kg/m2 ( according to WHO)
5. Patients willing to sign informed consent and able to participate in the study procedure. |
|
| ExclusionCriteria |
| Details |
1. Known case of Diabetes Mellitus, Insulin Dependent Diabetes, Juvenile Diabetes Mellitus and Gestational Diabetes.
2. known case of Major Systemic Diseases like IHD, Malignancies, Uncontrolled Hypertension.
3. Patients on prolonged medication ( more than 6 weeks) with Corticosteroids or any other Drug that may have an influence on the outcome of the study.
4. Pregnant and lactating women.
5. Patients with active infective diseases like Tuberculosis, Hepatitis B.
6. Immunocompromised patients.
7. Patients not suitable for basti karma)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To normalize glycemic state and improve quality of life in prediabetic patients |
10 days of treatment and followup on the 16th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of modified mustadi yapana basti & bhadranimbadi asthapana basti
To compare the efficacy of modified mustadi yapana basti & bhadranimbadi asthapana basti
Standardization of modified mustadi yapana basti & bhadranimbadi asthapana basti
To assess the specific probiotic strains of lactobacillus in modified mustadi yapana basti & bhadranimbadi asthapana basti through microbiological analysis
To study the role of modified mustadi yapana basti & modified bhadranimbadi asthapana basti in improving gut microbiota in pre-diabetes
|
8 days of treatment(basti chikitsa) & followup on 16th 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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="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
Modification(s)
|
Rationale: Prediabetes carries high
conversion risk in India (~18%/year) with no specific pharmacological treatment
in modern medicine beyond lifestyle advice. Ayurveda frames it as a
Kapha-predominant, Bahudoshaja state where kledaharana through Shodhana
— specifically Niruha Basti — is the treatment of choice. Both formulations are
modified by substituting Takra as the Basti dravya (Deepana, Kaphahara,
agni-stimulating, and probiotic in nature). Aim: Compare efficacy of the two
modified Bastis with lifestyle modification in prediabetes. Objectives: (1) comparative clinical efficacy;
(2) identification of Lactobacillus probiotic strains in the
formulations; (3) effect on gut microbiota via stool culture; (4)
pharmaceutical–analytical standardisation. Design: Randomised comparative clinical
trial, n=20 (Group A MMYB / Group B MBAB, 10 each), 18-month study duration,
follow-up 16 days. Ages 18–60, HbA1c 5.7–6.4%, BMI 22.2–29.9, Basti-arha.
Standard exclusions (diagnosed DM, pregnancy, major systemic illness,
immunocompromise). Intervention: Deepana-pachana with Chitrakadi
Vati, Sadyo Virechana with Eranda taila, then 480 ml Basti daily × 8 days,
Nati-kshudharta state.
Assessment: Subjective — Angasada, Sheeta
priyatva, Atisweda, Karapadadaha, Shithilangata, Gala-talu shosha (0–3 scales).
Objective — FBS, OGTT, HbA1c, urine, CBC, stool culture (pre/post). Plus
organoleptic, pH, viscosity, RI, ash value, HPTLC and emulsion tests on three
samples of each formulation. |