Effectiveness of Darvyadi Kwath and Nishamlaki Churna in Diabetes Mellitus

Phase 4

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

• Registration Number: CTRI/2022/04/042107
• Lead Sponsor: Chaudhary Brahm Prakash Ayurved Charak Sansthan

Brief Summary

*Madhumeha* is a clinical entity described in ayurveda as one of the types of *VatajaPrameha*. It is also mentioned that *Madhumeha* urine is sweet, slightly turbid and pale in color just like honey1 and each and every part of the body is sweetened in this disease. *Madhumeha* is *Santarpan ahara viharjanya vyadhi* in which *Kapha Dosha* and *Meda Dhatu Dushya* is dominant. The cardinal feature of *prameha* has been mention “*avila prabhuta mutra*â€. Main causes of the disease mainly excessive use of dairy products, sugar products, *navdhanya*, rice, sea food, excess sleep, lack of exercise. *Tridosha* responsible for disease as *prameha* which is characterized by *dhushyas* such as *Med, rakta, vasa, lasika, mansa, rasa, oja, kleda, majja, shukra* . Symptoms of *prameha* includes, excessive thirst, *prabhutavilmutra*, *hast pad taldaha, gurugatrata, swedadhikya, atinidra, kshudhadhikya, daurbalya*. In *Margavaranjanya Madhumeha* the vitiated *Kapha* and *Meda* obstructthe passage of *Vata*. The obstructed *Vata* is vitiated again and carries *Ojas* to *Basti* thus manifests *Madhumeha7*. In *Madhumeha kapha* is increase and mix with *kleda*. *Kleda* and *meda* is similer in nature. Excessive *kleda* mix with *kapha* goes to *vasti* and due to *gurutva guna do srotoavrodh* and manifest disease.

These clinical manifestations are similar to manifestations of a clinical entity named as Diabetes mellitus. Diabetes Mellitus is a group of common metabolic disorders that share the phenotype of hyperglycemia. Depending on the etiology of the Diabetes Mellitus, factors contributing to hyperglycemia include reduced insulin secretion, increased insulin resistance leading to decreased glucose utilization.

For treatment of *Madhumeha*, it is said that physician should decide upon the therapeutic measures based on disease and strength of *dosha*.

 ***Darvyadi kwath*****:** is herbal formulation for treatment of *Madhumeha* as mentioned in several proportion.

*Daruharidra* is *tikta* (~bitter) and *kashaya* (~astringnt) in *rasha* and *virya* is *ushna* (~hot potency) and *Prabhava* is *Kaphaghna**Devdaru* is *tikta* (~Bitter) *rasha* and *virya* is *ushna* (~hot potency) and *Prabhava* is *Vatakaphaghna*. *Nagarmotha tikta* (~bitter), *katu* (~pungent) and *kashaya* (~astringnt) in *rasha* and *Prabhava* is *Kaphapittaghna*.*Amalaki* is *panch rasha* without *lavna rasha and virya is ushna* (~hot potency) and *Rasayana Haritki* is *panch rasha* without *lavna rasha and virya is ushna* (~hot potency) and *Rasayana Vibhitki* is Kashaya (~astringnt) *rasha and virya* is *ushna* (~hot potency) and *Vipaka* is *Madhura* and *Prabhava* is *Tridoshar* and *Pitta Shamak.*Ayurveda has two ways of treatment viz. *sodhan* (purification) and *shamana Chikitsa* (pacificatory management). The etio-pathogenesis of *Madhumeha*, *Shamana Chikitsa* must be done with such drugs that possess *Agni Deepana* (digestion and metabolism enhancing) and *Kleda nasaka* (moistness removing) the aggravated *Dosha*. Drugs having Tikta (bitter), *Kashaya* (astringent) and *Rooksha* (dry) properties are mostly used in the management of *Madhumeha*. *Darvyadi Kwatha* possess above mentioned properties required for the management of *Madhumeha* (Diabetes)1

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-05
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Patients fulfilling the diagnostic criteria for Diabetes Mellitus framed by the AMERICAN DIABETES ASSOCIATION.
• FBS-126-250mg/dl 3.
• PPBS 180-400mg/dl 4.
• HbA1c 6.4 % and more.
• 5.Patient is taking anti oral diabetic medicine sulphonylureas dosage (glipizide not more then 20mg, glimipride not more then 8mg, glidazidie not more than 180 mg, pioglitazoe not more than 20 mg ) and bigunoids (metformin not more than 1000 mg) 6.
• Diagnosed case of Diabetes mellitus at least 6 month back.

Exclusion Criteria

• Patients below the age of 21 years and more than the age of 60 years.
• Fasting Blood Sugar Level >250 mg/dl • 3.
• Post Prandial Blood Sugar Level >400 mg/dl 4.
• Patients depending on the insulin for blood glucose control.
• Patients with diabetic complications.
• Gestational diabetes.
• Pregnant ladies and lactating mothers.
• Patient is taking any other oral anti diabetic medicine or combination of any oral anti diabetic medicine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the value of FBS, Glucose in urine and HBA1C	Day1, Day28, Day56, Day84

Secondary Outcome Measures

Name	Time	Method
Improvement in graded symptom of Dhatusamyata andVikaropshama Madhumeha	Day1, Day28, Day56, Day84

Trial Locations

Locations (1)

Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najagfarh New Delhi; 🇮🇳 West, DELHI, India

Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najagfarh New Delhi

🇮🇳West, DELHI, India

Dr Yogesh Kumar Pandey

Principal investigator

9013858523

dryogeshpandey@gmail.com