Comparative clinical study of wild and cultivated varieties of Amalaki for Rasayana effect in the Akalaja jara

Phase 2/3

Completed

Conditions: Healthy human volunteers possessing Akalaja jara lakshana

Registration Number: CTRI/2023/08/056111

Lead Sponsor: Government Ayurved Hospital Vadodara

Brief Summary: Clinical study has obtained InstitutionalEthics committee clearance (GAC/VAD/IEC/83/2023, Date-24/01/2023) andregistered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2023/08/056111,[Registered on 04/08/2023]. Study type was single blind parallel arm randomizedclinical trial. 48 volunteers were enrolledand divided into four groups (i.e., Group-A, Group-B, Group-C and Group-D) and12 volunteers in each group were allocated. Total 45 volunteers (i.e. 12volunteers in group A, 10 volunteers in group B, 12 volunteers in group C and11 volunteers in group D) have completed the study. All individual four groupswere having significant difference percentage in *Akalaja Jara*. Data analysis of cardinalsymptoms showed that, for *Twaka Rukshta* Group-C (NA-5 variety) hadbetter percentage of result i.e. 33% compared to other trial groups. For *Khalitya*Group-A (Wild variety) had better result i.e. 33% compared to other trialgroups. For *Agnisaad* Group- A (Wild variety) had better result i.e. 58%compared to other trial groups. For *Utsahhani* 8% result was observed inGroup-A (Wild variety) and Group-C (NA-5) compared to other trial groups. InGroup-A and Group-D, statistically significant difference was found in *Agnisaad.*While,non-significant difference observed in-between groups. In overall effect oftherapy mild improvement was observed 25%, 20%, 16.67% and 18.18% in Group-A,Group-B, Group-C and Group-D respectively and no change was observed 75%, 80%,83.33% and 81.81% in Group-A, Group-B, Group-C and Group-D respectively.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 10

Inclusion Criteria

Volunteers between the ages of 18 to 30 years with clinical features of Akalaja Jara.
Irrespective of gender Volunteers with 4 or more symptoms of Akalaja Jara.
Volunteers who are willing to participate.

Exclusion Criteria

Volunteers having age less than 18 years and more than 30 years Volunteers with any type of psychiatric disorder like Alzheimerâ€™s disease, Parkinsonism, Schizophrenia etc.
Volunteers with any diseases like carcinoma, IHD, Hepatic and renal insuffiency, IBS or Dhatukshayatva involved in the pathophysiology of disease like Madhumeha, Rajyakshama etc.
Pregnant women, Lactating mothers.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Utsahhani	4 weeks

Secondary Outcome Measures

Name	Time	Method
Twak rukshta, Vali, Khalitya, Palitya, Agnisad	4 weeks

Trial Locations

Locations (1): Government Ayurved Hospital, Vadodara
🇮🇳
Vadodara, GUJARAT, India
Government Ayurved Hospital, Vadodara
🇮🇳Vadodara, GUJARAT, India
Dr Jyoti D Bhagiya
Principal investigator
8866158609
jyotibhagiya18598@gmail.com