| CTRI Number |
CTRI/2025/06/088678 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess add-on effect of Coriander seed cold decoction with Shitali Pranayam in Hyperacidity patients of age group 18-45 years |
|
Scientific Title of Study
|
A comparative clinical trial to assess the add-on effect of Dhanyak Hima (Coriandrum sativum Linn.) with Shitali Pranayam in Urdhvaga 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 |
Vd Payal Deorao Bhandekar |
| Designation |
PG Student |
| Affiliation |
Department of Swasthavritta and Yoga PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
Opd 123 B Department of Swasthavritta and Yoga PDEAs College of Ayurved and Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423838842 |
| Fax |
|
| Email |
payalbhandekar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Manore |
| Designation |
Associate professor MD |
| Affiliation |
Department of Swasthavritta and Yoga PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
Department of Swasthavritta and Yoga PDEAs College of Ayurved and Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9881650526 |
| Fax |
|
| Email |
dr.manore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Payal Deorao Bhandekar |
| Designation |
PG Student |
| Affiliation |
Department of Swasthavritta and Yoga PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
Opd 123 B Department of Swasthavritta and Yoga PDEAs College of Ayurved and Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423838842 |
| Fax |
|
| Email |
payalbhandekar97@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Nigdi Pune 411044 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Vd Payal Deorao Bhandekar |
| Address |
PDEAs College of Ayurved and Research Centre Nigdi Pune 411044 Maharashtra India |
| Type of Sponsor |
Other [Private Ayurved College ] |
|
|
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 |
| Vd Payal Deorao Bhandekar |
PDEAs Ayurved Rugnalaya and Snowbell Multispeciality Hospital |
Opd no 123B Swasthavritta Department PDEAs Ayurved Rugnalaya and Snowbell Multispeciality Hospital Nigdi Pune
Pune
MAHARASHTRA |
9423838842
payalbhandekar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Shitali Pranayam and Dhanyaka Hima | (Procedure Reference: Tripathi H Hathyogapradipika, Procedure details: Sitting in Padmasana or Siddhasana, air will be drawn in through the mouth while keeping the tongue between the lips. The breath will then be held according to capacity. The air thus drawn in will be expelled through both nostrils not through the mouth. This constitutes one cycle, likewise 10 repetitions will be done daily for 10 days.)
(1) Medicine Name: Dhanyaka, Reference: Pandit N Rajnighantu Pippalyadivarga verse 37, Route: Oral, Dosage Form: Sheeta/Hima, Dose: 100(ml), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | Shitali Pranayam | (Procedure Reference: Tripathi H Hathyogapradipika, Procedure details: Sitting in Padmasana or Siddhasana, air will be drawn in through the mouth while keeping the tongue between the lips. The breath will then be held according to capacity. The air thus drawn in will be expelled through both nostrils not through the mouth. This constitutes one cycle, likewise 10 repetitions will be done daily for 10 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 18-45 years having symptoms of Amlapitta Daha, Amlodgara, Shula, Chhardi, Adhman, Gaurav, Avipak and Aruchi irrespective of sex and religion.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy, Lactation and Children.
2.The secondary causes will be excluded.
3.Patients taking any type of antacids. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the add-on effect of Dhanyaka Hima with Shitali Pranayam given for 10 days in Urdhvaga Amlapitta. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/06/2025 |
| 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="0"
Months="6"
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 condition in which exaggeration of Vidahi and Amla Guna of pitta dosha takes place is known as Amlapitta which is characterised by Daha (Burning sensation heartburn), Amlodgara(acid eructations), Shula(Pain), Aruchi(loss of sensation of taste), Chhardi(vomiting), Avipak(indigestion), Adhman(distention of abdomen) and Gaurav(heaviness in abdomen and body). Normally, Pitta has Katu rasa, but in Amlapitta condition, it gets converted to amla rasa. Dhanyaka is Katu, Kashay and Madhura in Rasa, Sheet in Virya, Madhura in Vipak. It has Pittanashan, Deepan as well as Pachan properties. It is included in Sheetaprashaman mahakashay. Shitali Pranayam is effective on Pitta dosha as mentioned in Hathayogapradipika. So this study aims to assess the add-on effect of Dhanyaka Hima with Shitali Pranayam in Urdhvaga Amlapitta. |