| CTRI Number |
CTRI/2026/01/100493 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effect of Amla Candy in management of Urdhwag Amlapitta in 60
participants. |
|
Scientific Title of Study
|
study the add-on effect of Amla candy as a Pathya in the management of Urdhwaga Amlapitta. |
| 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 Manisha Dattatrya Kadam |
| Designation |
PG Student |
| Affiliation |
MAMs Sumatibhai shah Ayurved Mahavidyalay, Hadapsar |
| Address |
Special OPD No.3 Department of swasthavritta and yoga, Sane Guruji Arogya Kendra, Hadapsar, pune
Special OPD No. 3 Department of swasthavritta and yoga, Sane Guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9284601883 |
| Fax |
|
| Email |
manishakadam344@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Dattatrya Kadam |
| Designation |
PG Student |
| Affiliation |
MAMs Sumatibhai shah Ayurved Mahavidyalay, Hadapsar |
| Address |
Special OPD No.3 Department of swasthavritta and yoga, Sane Guruji Arogya Kendra, Hadapsar, pune
Special OPD No. 3 Department of swasthavritta and yoga, Sane Guruji Arogya Kendra, Hadapsar, Pune
MAHARASHTRA
411028
India |
| Phone |
9284601883 |
| Fax |
|
| Email |
manishakadam344@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Ujwale |
| Designation |
HOD Department of Swasthavritta and Yoga |
| Affiliation |
MAMs Sumatibhai shah Ayurved Mahavidyalay, Hadapsar |
| Address |
Special OPD no. 3 Department of swasthavritta and yoga, sane Guruji Arogya Kendra, Hadapsar, Pune
Special OPD No. 3 Department of swasthavritta and yoga, Sane Guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9922008027 |
| Fax |
|
| Email |
ujwale_rs@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthavritta and Yoga, Sane Guruji Arogya Kendra, Malvadi, Hadapsar, Pune India 411028 |
|
|
Primary Sponsor
|
| Name |
Sane guruji Arogya Kendra |
| Address |
Sane guruji Arogya Kendra, Hadapsar, Pune iIndia 11028 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manisha kadam |
MAMs Sumatibhai Shah Ayurveda Mahavidyalaya, Hadapsar, Pune 28 |
Special OPD
NO.3,Department of
Swasthavritta, Sane Guruji
Arogya Kendra, Malvadi
Hadapsar. Department of
Swasthavritta, MAMs
Sumatibhai Shah Ayurveda
Mahavidyalaya, Hadapsar,
Pune 28. Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9284601883
manishakadam344@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMS SSAM And SANE GURUJI AROGYA KENDRA, HADAPSAR, PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E888||Other specified metabolic disorders. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amla candy, Reference: Bhavpraksha , Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: 1)Getting up 45 minutes before sunrise
2) practice yoga and Pranayam
3)matravata ahar sevan
, Ritucarya: Follow Grishma and Sharada Rutucharya , Acara Rasayana:Person should speak always satya( truth) should avoid krodha (anger), himsa(violence). Should not hurt anyone mentally and physically.
Habitually take milk and ghee., Other:NA, Pathya/Apathya:yes, Pathya:Ahar-Intake of Madhura, sheeta, Drava, Snigdha, paya, ghrita.
Vihar-one should wear pearls, apply sandalwood as a lepana, , Apathya:Ahar-One should avoid Apathya lavana, Amla, Ushna, Katu, Madyapana, vidahi, paryushita bhojana.
Vihar-Ativyayama, Ratrijagrana, Diwaswapa. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Recently diagnosed patients of urdhwaga amplapitta having symptoms since 5 to 6 months |
|
| ExclusionCriteria |
| Details |
patients suffering from Diabetes Mellitus, Hypertension and Thyroid, chronic disease like gastric ulcer, etc. addictions like alcohol, smoking, tobacco etc, or pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study add on effect of amla candy as a pathya in the management of urdhwaga amplapitta. |
The parameters of efficacy of Amla Candy will be evaluated by observing patients through subjective criteria at regular intervals
0th,14th, 30th days follow up. The relief of sign and symptoms of
Amlapitta will be evaluated with the help of questionnaire and to check Apunarbhavatwa the next follow up will be taken after 45th days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/01/2026 |
| 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
|
Efficacy of amla candy will be evaluated by observing patients through subjective criteria at regular intervals at 0, 14, 30 day of follow up also apunarbhavatva will be examined after 45 days. The relief of signs and symptoms will be evaluated with the help of questionnaire |