IMPACT OF VAMANA KARMA(THERAPEUTICALLY INDUCED EMESIS) AND TRIPHALA AND GUDUCHI CHURNA WITH MADHU ON THE MODULATION OF GUT MICROBIOTA.
- Conditions
- Healthy individuals as per Proforma for Health Assessment by self-reporting of CSIR Ayurgenomics Unit- TRISUTRA CSIR-IGIB, NEW DELHIType 2 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,
- Registration Number
- CTRI/2020/12/030107
- Lead Sponsor
- All India Institute of Ayurveda
- Brief Summary
**This is a comparative study to investigate the effect of *Vamana Karma* and *Triphala Churna* and *Guduchi Churna* with *Madhu* on the gut microbiota and metabolite patterns in *Prameha* W.S.R to Type 2 Diabetes Mellitus and Healthy Individuals as well as to compare the effect of *Vamana Karma* followed by administration of *Triphala Churna* and *Guduchi Churna* with *Madhu* and administration of Only T*riphala Churna* and *Guduchi Churna* with *Madhu* in the patients of *Prameha* W.S.R Type 2 Diabetes Mellitus.**
Diet and lifestyle modification being an integral part of *Vamana* *Karma*(therapeutic emesis for internal bio-cleansing) may lead to the modification of environmental microflora in a positive aspect for shaping the healthy human microbiota composition thus leading to the state of wellness. This whole information gives a lead that *Vamana* therapy aims at modulating the gut functioning and thereby restoring the state of homeostasis, improving digestion and metabolism in turn proved to be an effective treatment modality in many diseased conditions like Rheumatoid arthritis, skin disease, Type 2 diabetes mellitus, allergic conditions etc. Therefore, this study can investigate the role of classical *Vamana*therapy as described in Ayurveda by showing its impact in the modulation of dysbiosis and hence it can emerge as a proven modality of treatment in variety of metabolic, immune mediated, neuropsychiatric and musculo-skeletal diseased conditions.
The study contains the following three groups-
1. Group 1-*Prameha*Patients (*Vamana Karma* followed by *Triphala*and*Guduchi Churna*with *madhu*)- 15 subjects
2. Group 2- *Prameha*Patients (Administration of only *Triphala*and *Guduchi Churna*with *madhu*)- 15 subjects
3. Group 3 - Healthy Individuals (*Vamana Karma* followed by *Triphala* and *Guduchi Churna*with *madhu*)- 15 subjects
The above mentioned three groups have been taken with an objective to compare the effect of *Vamana Karma* followed by *Triphala Churna* and *Guduchi Churna* with *Madhu* and administration of only *Triphala Churna* and *Guduchi Churna* with *Madhu* in the patients of *Prameha* W.S.R to Type 2 Diabetes Mellitus with respect to change in Sign and symptoms, Plasma Glucose Level and gut Microbiota and metabolite patterns i.e Group 1 and Group 2.
It will also compare the alterations being seen on the gut microbiota and metabolite patterns in both the Prameha and Healthy Individuals undergoing Vamana Karma followed by administration of Triphala and Guduchi churna with Madhu i.e Group 1 and Group 3.
**RESEARCH QUESTION**
- **Is there any difference in the efficacy of *Vamana Karma* followed by *Triphala*and*Guduchi Churna* with *Madhu* and direct administration of *Triphala*and *Guduchi Churna* with *Madhu* in the management of *Prameha*(T2DM).**
- **Is there any difference in the impact of classical *Vamana Karma*followed by *Triphala*and*Guduchi Churna* with *Madhu* on the alteration of Gut Microbiota diversity and metabolite patterns in the patients of *Prameha*(T2DM) and healthy individuals as well as in the administration of direct *Triphala*and *Guduchi Churna* with *Madhu* in the patients of Prameha(T2DM) only.**
**HYPOTHESIS**
There is significant difference in the efficacy of *Vamana Karma*followed by *Triphala*and *Guduchi Churna*with*Madhu*as compared to direct administration of *Triphala*and *Guduchi Churna*with*Madhu* in the management of *Prameha*.
There is significant difference in the impact of classical *Vamana karma*followed by *Triphala*and *Guduchi Churna*with*Madhu*on the alteration of Gut Microbiota diversity and metabolite patterns in the patients of *Prameha*(T2DM) and healthy individuals as well as in the administration of direct *Triphala*and *Guduchi Churna*with*Madhu* in the patients of *Prameha*(T2DM) only.
**OBJECTIVES OF THE RESEARCH PROJECT****:**
**PRIMARY:**
1. To compare the efficacy of *Vamana* *Karma* followed by administration of *Triphala*and *Guduchi Churna*with*Madhu* and administration of only *Triphala*and *Guduchi Churna*with*Madhu* in the management of Prameha(w.s.r to T2 DM).
2. To see the impact of Classical *Vamana karma* followed by administration of *Triphala*and *Guduchi Churna*with*Madhu* on gut microbiota diversity and metabolite patterns in Prameha (w.s.r Type 2 Diabetes).
**SECONDARY:**
1. Whole microbiome and metabolome Analysis of both *Prameha* and healthy individuals to see the impact of classical *Vamana* karma on Gut Microbiome and metabolomes.
2. To evaluate change in Plasma Glucose level in the patients of *Prameha* (w.s.r T2 DM).
3. To improve the quality of life.
**METHODOLOGY-**
**TYPE OF STUDY DESIGN**
- Experimental Study
- Triple armed controlled clinical trial.
**SAMPLE SIZE CALCULATION**
This type of study is being done first time and further the experimental procedures and tests are costly. Therefore, seeing the feasibility we have decided to take 15 individuals in each group.
1. Group 1- *Prameha*Patients- (*Vamana Karma* followed by *Triphala*and*Guduchi Churna*with *madhu*)- 15 Subjects
2. Group 2- *Prameha*Patients(Administration of only *Triphala*and *Guduchi Churna*with *madhu*)- 15 Subjects
3. Group 3-Healthy Individuals (*Vamana Karma* followed by *Triphala* and *Guduchi Churna*with *madhu*)- 15 Subjects
Total Sample Size = 45
**SAMPLE COLLECTION** -
Cases (group 1 and group 2) will be recruited attending the OPD& IPD of AIIA, fulfilling the diagnostic criteria as per WHO latest guidelines for T2DM and Clinical Proforma for *madhumeha*(T2DM) of CSIR Ayurgenomics Unit- TRISUTRA CSIR-IGIB, NEW DELHI
The subjects will be allocated to above 2 groups by randomisation. The 30 random numbers will be picked from random number table. The odd numbers will be allocated to Group A and even numbers to Group B and will receive their respective treatments.
Controls (group 3) will be recruited as per Proforma for Health Assessment by self-reporting and Prakriti Assessment Proforma of CSIR Ayurgenomics Unit- TRISUTRA CSIR-IGIB, NEW DELHI.
**DRUG DELIVERY REGIMEN (DRUG, DOSE DURATION, FOLLOW-UP, WITHDRAWAL)**
**In Group 1 and 3-**
**Stepwise administration of-**
**1.*Deepana-Pachana***
- ***Shunthi churna* - 3gm BiD**
- ***Nagarmotha churna* - 3gm BiD**
**For 3-7 Days until *samyaka langhana lakshanas* are observed**
***2. Snehapana-***
***Murchita-Goghritam* (*Aarohana krama* i.e in increasing dose starting from 40 ml)**
**For 3-7 days until *samyaka snigdha lakshanas* are observed**
3. ***Abhayangam*****–**
**With *Tila Taila* (Q.S)- For 30-35 minutes**
**For 1 Days and on the day of *Vamana***
***4. Swedanam***
***Dashmulakwath sarvang mridu bashpa sweda*(whole body sudation with *Dashmula kwath* till *samyak swinna lakshanas* are observed)**
**For 1 Days and on the day of *Vamana***
***5. Vamana***
1. ***Madanaphala-phala-pippali churna= 6gm(Antarnakhmushti pramana)*Soaked in *Yashtimadhu kashaya*overnight**
2. ***Saindhav = 2.5gm***
3. ***Madhu = Q.S***
4. ***Yashti Kashaya = 150ml***
**After aakantha-yavagu-pana/dugdhapana(complete filling of stomach with gruel or milk)**
**For a single time and day**
***6. Samsarjan karma***
**A systematised and gradual administration of wholesome diet plan**
**For 3-7 days depending upon *Vamana* vega(frequency of purgations).**
**7. Oral Administration of *Triphala*and*Guduchi Churna*with*Madhu***
- ***Triphala Churna*(3gm) mixed with *madhu*(3gm) - BiD (before food)**
- ***Guduchi Churna*(3gm) mixed with *madhu*(3gm) – BiD (after food)**
**For 15 days**
**In Group 2**
- **Oral Administration of *Triphala*and*Guduchi Churna*with*Madhu***
1. ***Triphala Churna*(3gm) mixed with *madhu*(3gm) - BiD (before food)**
2. ***Guduchi Churna*(3gm) mixed with *madhu*(3gm) – BiD (after food)**
**For 30 days**
**Total no. of Days treatment given**
Total number of days **for Group 1 and Group 3** (with an average of *Deepana-Pachana , Snehana* , *Abhyanga*, *Swedana*, *Vamana*and *Samsarjan krama* is 11-23 Days ) + (*Triphala*-*Guduchi Churna*with *madhu* – 15 days) = Between 26-38 days
**In Group 2**
- Oral Administration of *Triphala*and *Guduchi Churna*: for 30 days
Total number of days for Group 2 = 30 Days
**Follow-up Period****-**
At 15th day and 30th day after completion of treatment
**PARAMETER FOR ASSESSMENT OF STUDY OUTCOMES**
- **Reduction in Sign and Symptoms of *Prameha*(T2DM)patients(By questionnaire Scoring Pattern).**
- **Microbiota and metabolite analysis of faecal matter, oral swab and vomitus sample through 16s rRNA technology.**
- **Plasma Glucose level through intravenous blood sample of the patients.**
- **QOL Questionnaire**
**Collection of specimens**
- **Faecal Sample**
- **Oral swab**
- **Vomitus sample\***
- **Blood Sample\***
**\*Note- Vomitus and Blood sample(for molecular analysis simultaneously along with the blood sample to be collected for Plasma Glucose level test) will also be collected for future analysis if resources and time would allow.**
**RESPONSE CALCULATION AND ASSESSMENT OF RESPONSE:**
The primary outcome measure of this study is to determine the response (R) of the patients to the therapy and it is proposed to be measured in terms of the -
- Reduction in sign and symptoms of *prameha* and plasma glucose levels.
- Absence/reduction in the microbiota and metabolites associated with Type 2 Diabetes Mellitus and which are not beneficial for metabolism.
- Presence/increase in microbiota and metabolites helping in the prevention of T2DM and which are beneficial for metabolism.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 45
- For Prameha(Type 2 Diabetes Mellitus) Individuals- 1.
- Kaphaj/Kapha-pittaj Vikriti predominant individuals 3.
- Diagnosed cases of Prameha/Madhumeha/T2DM with either of the following- a) Fasting plasma glucose values of ≥ 7.0 mmol/L (126 mg/dl) b) 2-h post-load plasma glucose ≥ 11.1 mmol/L (200 mg/dl) c) HbA1c ≥ 6.5% (48 mmol/mol) d) Random blood glucose ≥ 11.1 mmol/L (200 mg/dl) 4.
- Kaphaj/Kapha-pittaj Prakriti predominant Individuals as per Proforma for Prakriti Assessment by CSIR Ayurgenomics Unit- TRISUTRA CSIR-IGIB, NEW DELHI 3.
- Healthy individuals as per Proforma for Health Assessment by self-reporting of CSIR Ayurgenomics Unit- TRISUTRA CSIR-IGIB, NEW DELHI.
- Patients unfit for Snehana(Internal Oleation), Svedana(Sudation), Vamana(therapeutically induced emesis for internal bio-cleansing).
- For Prameha(Type 2 Diabetes Mellitus)- 1.
- Patients with T2 DM exceeding the following plasma glucose limits- a) Fasting plasma glucose values of ≥ 300mg/dL b) 2-h post-load plasma glucose≥400mg/dL c) Random blood glucose≥ 400mg/dL 2.
- Chronicity: More than 10 years.
- Known cases of Severe systemic diseases like- Cardiac disease, pulmonary tuberculosis, severe lung disease, uncontrolled diabetes and pregnant women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Sign and Symptoms of Prameha(T2DM)patients(By questionnaire Scoring Pattern). 56-68 days To see the impact of Classical Vamana karma followed by administration of Triphala and Guduchi Churna with Madhu on gut microbiota diversity and metabolite patterns in Prameha (w.s.r Type 2 Diabetes Mellitus). 56-68 days
- Secondary Outcome Measures
Name Time Method Whole microbiome and metabolome Analysis of both Prameha and healthy individuals to see the impact of classical Vamana karma on Gut Microbiome and metabolomes. To evaluate change in Plasma Glucose level in the patients of Prameha (w.s.r T2 DM).
Trial Locations
- Locations (1)
All India Institute of Ayurveda
🇮🇳South, DELHI, India
All India Institute of Ayurveda🇮🇳South, DELHI, IndiaNISHANT MALHOTRAPrincipal investigator8130711860nishantmalhotra9.nm@gmail.com