CTRI/2024/08/072456 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On:
09/08/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Other
Public Title of Study
To evaluate the efficacy of Nagabala ghrita and Gandha taila as Matra basti and Brihmana sneha orally in Asthi kshaya w.s.r to Calcium deficiency in children.
Scientific Title of Study
Randomised comparative clinical study to evaluate the efficacy of Nagabala Ghrita and Gandha taila as Matra Basti and Brihmana Sneha orally in Asthi Kshaya with special reference to Calcium deficiency in children.
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 Reshmi S Nair
Designation
PG Scholar
Affiliation
Sri Sri College of Ayurvedic Science and Research,Bangalore
Address
Room no 9,Kaumarabhritya OPD, Sri Sri College of Ayurvedic Science and Research Hospital,21st km Kanakapura Road,Udayapura,Bangalore,Karnataka 560082, India
Bangalore KARNATAKA 560082 India
Phone
8123563801
Fax
Email
reshmisnair19@gmail.com
Details of Contact Person Scientific Query
Name
Dr Divyasri RA
Designation
Professor
Affiliation
Sri Sri College of Ayurvedic Science and Research,Bangalore
Address
Room no 9,Kaumarabhritya OPD, Sri Sri College of Ayurvedic Science and Research Hospital,21st km Kanakapura Road,Udayapura,Bangalore,Karnataka 560082, India Room no 9,Kaumarabhritya OPD, Sri Sri College of Ayurvedic Science and Research Hospital,21st km Kanakapura Road,Udayapura,Bangalore,Karnataka 560082, India Bangalore KARNATAKA 560082 India
Phone
9448939421
Fax
Email
divya_mesha@yahoo.co.in
Details of Contact Person Public Query
Name
Dr Reshmi S Nair
Designation
PG Scholar
Affiliation
Sri Sri College of Ayurvedic Science and Research,Bangalore
Address
Room no 9,Kaumarabhritya OPD, Sri Sri College of Ayurvedic Science and Research Hospital,21st km Kanakapura Road,Udayapura,Bangalore,Karnataka 560082, India
Bangalore KARNATAKA 560082 India
Phone
8123563801
Fax
Email
reshmisnair19@gmail.com
Source of Monetary or Material Support
Sri Sri College of Ayurvedic Science and Research, Hospital
Primary Sponsor
Name
Dr Reshmi S Nair
Address
Room no 9,Kaumarabhritya OPD, Sri Sri College of Ayurvedic Science and Research Hospital,21st km Kanakapura Road,Udayapura,Bangalore,Karnataka 560082, India
Type of Sponsor
Other [Self]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Reshmi S Nair
Sri Sri College of Ayurvedic Science & Research
Room no 9 Kaumarabhritya OPD Sri Sri College of Ayurvedic Science and Research Hospital
21st km Kanakapura Road Udayapura Bangalore Karnataka 560082 India Bangalore KARNATAKA
(Procedure Reference: Kashyapa Khialsthana,Chapter 8,Verse 104-105, Procedure details: Poorva karma: Subjects will be asked to come for the treatment immediately after taking food, Stanika abhyanga to abdomen, buttocks and thighs will be done for 20 minutes and Nadi Sweda with Ushna jala will be done for 10 minutes.
Pradhana karma: Subjects will be asked to lie in the left lateral position by keeping the left leg straight and the right leg flexed at the knee joint. Under aseptic precautions, the anus will be anointed by using a cotton swab dipped in oil and Drug will be administered using a rubber catheter attached to a syringe.
Paschat karma: Gentle massage over the abdomen, back and plantar region will be done after Basti administration.
) (1) Medicine Name: Nagabala ghrita, Reference: Ashtanga Hridaya,Chikitsa sthana,Chapter 3, Verse 120-125, Route: Rectal, Dosage Form: Ghrita, Dose: 24(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: Gandha taila, Reference: Ashthanga Hridaya,Uttarasthana,Chapter 27/36-41, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days
Inclusion Criteria
Age From
3.00 Year(s)
Age To
6.00 Year(s)
Gender
Both
Details
Subjects in the age group 3 years -6 years.
Subjects irrespective of their gender, religion and socio-economic status.
Subjects diagnosed with classical symptoms of Asthi kshaya.
Subjects with classical symptoms of Calcium deficiency. Subjects whose parents are willing to sign the written consent form and follow the treatment protocol will be included.
Subjects with mild to moderate calcium deficiency.
ExclusionCriteria
Details
Severe cases of Hypocalcemia with Tetany, Seizures, Paresthesia, Laryngospasm, Bronchospasm and Arrhythmia.
Subjects with any Congenital Anomalies.
Subjects with Endocrinal disorder related to growth.
Subjects with Metabolic disorders.
Subjects with Malabsorption Syndromes.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Significant improvement in the clinical features of Asthi Kshaya and Calcium deficiency
Within one year of the study.
Secondary Outcome
Outcome
TimePoints
Generation of in-depth analysed data on the different aspects of the disease.
Generation of data on possible unexpected drug reactions.
Within one year of the study
Target Sample Size
Total Sample Size="30" Sample Size from India="30" 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
Phase 3
Date of First Enrollment (India)
20/08/2024
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="0" 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
The period of childhood is recognized as a phase of significant growth, wherein optimal growth is attained through a well-balanced diet and the absence of disease.1 Due to increased growth and metabolism, the nutritional requirements of children are higher compared with adults.Among all the other micronutrients, emphasis is made on Calcium. Calcium plays a key role in Skeletal mineralisation and is required for normal growth, development and bone strength.Micronutrient deficiencies affect an estimated two billion people, or almost one-third of the world’s population.2 Calcium, on the other hand, is at prevalence of deficiency, with 94% of the population at risk.3 The prevalence of Calcium deficiency, in urban school-going children and adolescents alone, in India was found to be about 59.9%.4In addition to Calcium, magnesium, phosphorus and Vitamin D also play a vital role in Bone health; Wherein, Vitamin D plays a main role in increasing the intestinal efficacy of Calcium absorption.Presently, calcium supplements are prescribed prophylactically in children to support healthy bone development and overall growth. There is a wide range of calcium supplements available in the market, each claiming various benefits, such as protecting against bone loss or preventing rickets but it is also important to monitor for its potential adverse effects and digestive issues such as constipation, bloating etc.Asthi Kshaya stands out, signifying a deficiency in the Asthi Dhatu. Wherein, Dalhana has defined Kshaya as ‘Swapramana Haani’.5Since Calcium and Phosphorus are major components of Asthi, Calcium deficiency can be considered as one of the major causes of Asthi Kshaya. Asthi Kshaya leads to Sthula dhatu Kshaya- Asthi Kshaya, Sukshma roopa Majja Kshaya, Upadhatu and Mala Kshaya with respect to Danta Nakha, Kesha and Twacha.Since Ayurveda considers Asthi as a deeper Dhatu, Asthi Kshaya Chikitsa involves Basti karma and employing substances with Snigdha,Guru Guna, Madhura-Tikta rasa dravyas which include Ksheera, Ghrita etc. T.In this regard, the current study is planned to do Dhatupratyaneeka Chikitsa i.e., Asthi Dhatu Kshaya as per the guidelines of the Classical texts by the use of Snigdha, Madhura, Brihmana Dravya Basti and Brihmana Sneha orally. Several Yogas are mentioned to be Brihmana, Balya, and Ojasya, but very few are clinically practised in the condition of Asthi Kshaya.In this context, Nagabala Ghrita, a classical formulation is a combination of drugs said to be Balya, Brihmana, Ojasya, Vali-Palityaghna Varnya, Rasayana etc. The biological activities of the genus Grewia (Nagabala)are said to have high contents of Calcium and are extremely important for curing severe pain in bones and also help to increase the mobility of joints.The Asthi-sthairyakrit and Vata shamaka Karma along with Balya, Brihmana, Dipana-Pachana, Keshya etc. Gunas of Gandha Taila dravyas make it a suitable choice in Asthi Dhatu Kshaya.This study is an effort to evaluate the efficacy of Nagabala Ghrita and Gandha Taila as MatraBasti and Brihmana Sneha orally in Asthi Kshaya with special reference to Calcium deficiency in children.