A comparative clinical study on the efficacy of vamana karma with ikshvaku yoga and darvyadi kwatha with life style modification in prameha w.s.r to prediabetes

A comparative clinical study on the efficacy of vamana karma with ikshvaku yoga and darvyadi kwatha with life style modification in prameha w.s.r to prediabetes

RESEARCH QUESTIONDoes eitherthe use of Vamana karma followed bythe oral administration of Darvyadi kwatha or the use of only Darvyadi kwatha without Vamana karma with the life stylemodification (Nidana parivarjana)have equal efficacy in managing Prameha w.s.rto Pre-Diabetes?

HYPOTHESISVamana karma followed by theoral administration of Darvyadi kwatha inthe dose of 80ml BD for 30 days before food has greater efficacy as comparedwith that of the only use of oral administration of Darvyadi kwatha in the dose of 80ml BD for 30 days before food withthe life style modification in managing Pramehaw.s.r to Pre-Diabetes.

NULLHYPOTHESIS- Vamana karma followed by Darvyadi kwatha do not have efficacy incomparison with that of oral administration of Darvyadi kwathaand the life style modification (Nidana parivarjana) in the management of Pre-Diabetes.

ALTERNATEHYPOTHESIS- Vamana karma followed by Darvyadi kwatha has more efficacy than oral administration of Darvyadi kwatha andthe life style modification in the management of Prameha w.s.r to Pre-Diabetes.

SETTINGClinicalsetup- OPD and IPD of AIIA, New Delhi.

 Group A: Classical Vaman karma with Ikshvaku yoga in schedule for 15 days followed by the oraladministration of Darvyadi kwatha inthe dose of 80ml twice a day before food with life style modification (Nidana pariverjana) for 1 month.

Group B: Oral administration of Darvyadi kwatha in the doseof 80ml twice a day before food with life style modification (Nidana pariverjana) for 1 month.

SAMPLE SIZE AND CALCULATION-With the lack of abundance in the literature (published Researcharticles), the proposed research project may be considered to be a PilotProspective study. Hence a sample size of 20 subjects per group will beenrolled in the study[15].

 PROCESS OF RANDOMIZATION:An unbiased and blockRandomization using computer generated random number.

 CRITERIA FOR SELECTIONINCLUSION CRITERIA·     Age between 30 years to 60 years.

·     Obese Patients.

·     HBA1C between 5.7% - 6.4%.

·     Fasting blood glucose 100 - 125mg/dl.

·     BMI > 25.

·     Waist to hip ratio

0

In case of Male > 0.95 In case of Female > 0.80

EXCLUSION CRITERIA·     IDDM patients.

·     Gestational diabetes.

·     Patients on steroids or oral Hypoglycemic drugs.

·     Malignant and accelerated Hypertension.

·     CCF.

·     Pregnant women.

·     Lactating mother.

·     Any serious disease condition.

·     Patients who are unfit for Vamana karma.

CRITERIA FOR DIAGNOSIS·     HBA1C between 5.7% - 6.4%

·     Fasting plasma glucose 100mg/dl - 125mg/dl

·     Oral glucose tolerance test(OGTT) 140mg/dl - 200mg/dl

·     BMI

 GROUPING AND DRUG DELIVERYREGIMEN (DRUG, DOSE DURATION, FOLLOW-UP, WITHDRAWAL CRITERIA, RESCUEMEDICATION)The following is the proposed graphical tree of thestudy design.

Setting and Location: OPD & IPD, AIIA

Eligible subjects with submission of written ethical permission

Block Randomization

GROUP A:

GROUP B:

Follow-up upto 120 day Follow-up will be done on 46th 76th 106th & 120th days.

Darvyadi kwatha in the dose of 80ml two times a day before food with life style modification (Nidana pariverjana) for 1 month.

Classical Vamana karma (it includes use of Pachana,Deepana Abhyanga,Swedana & Vamana karma followed by samsarjana krama) approximate duration of

15 days.

  |   |Darvyadi kwatha in the dose of 80ml twice a day before food with life style modification (Nidana pariverjana)

for 1 month.

|   |Follow-up upto 120 day Follow-up will be done on 46th 76th 106th & 120th days.

  |

Proposed Timeline of data collections, analyses, interpretations and report submission: Pl refer to Table- 2.

DRUGS AND DURATION:

The same are stated in Table-1.

Table – 1

Proposedtherapeutic procedures, drugs doses and time schedule

Procesure

Duration

Medicine

Dose

Time

|Deepana & Pachana

3 - 7 days (as per

requirement)

Nagarmotha Panchakola

5gm 5gm

TDS

|Snehapana

3 – 7 days (as per requirement)

Murchhita ghrita

Increasing

6am – 8am

Abhyanga

2 days

Tila taila

100ml

After Snehpana

|Bashpa Swedana

2 days

Dashmoola kwatha

50gm

After Abhyanga

|Vamana

1 day

Classical Ikshvaku yoga

6gm and conventional drugs of Vamana karma

After sunrise 6am – 8am

|Sansajgana Krama

3 – 7 days (as per requirement)

Peya, Vilepy Akrita yush Krita yush

According to Agni bala

lunch Dinner

|Samshamana medicine

30 days

Darvyadi kwatha

80ml twice a days

Before food

Before Vamana karma Sarvanga Abhyanga will bedone with Tila Taila & Mridu Bashpa Swedana will be done with Dashamoola Kwatha.

Drugs will be procured as per thepolicies of AIIA

 DURATION: 120 days

 FOLLOW-UP: upto 90 day; once in month and Follow-upwill be doneon 46th76th 106th & 120thdays.

Total number of follow-up is 4.